Radiometer Medical ApS
BROENSHOEJ Hovedstaden, DK
RADIOMETER MEDICAL APS appears in FDA device records in BROENSHOEJ Hovedstaden, DK. FDA records list 30 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 25 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 30 510(k) clearances for Radiometer Medical ApS between 2000 and 2017. The busiest year on record is 2005, with 5. The most recent is 2017, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 2 |
| 2004 | 1 |
| 2005 | 5 |
| 2006 | 1 |
| 2010 | 3 |
| 2011 | 2 |
| 2012 | 5 |
| 2013 | 5 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K163462 | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX | JHX | Substantially Equivalent | |
| K170882 | ABL90 FLEX, ABL90 FLEX PLUS | MQM | Substantially Equivalent | |
| K160153 | ABL90 FLEX PLUS | CHL | Substantially Equivalent | |
| K142898 | ABL800 FLEX with AQURE connectivity | CHL | Substantially Equivalent | |
| K150226 | Hematocrit and Metabolite QUALICHECK | JJS | Substantially Equivalent | |
| K132691 | ABL90 FLEX | MQM | Substantially Equivalent | |
| K131988 | ABL90 FLEX ANALYZER | CHL | Substantially Equivalent | |
| K130144 | ABL90 FLEX | CHL | Substantially Equivalent | |
| K123748 | ABL90 FLEX | CHL | Substantially Equivalent | |
| K130415 | HIGH METABOLITE QUALICHECK | JJS | Substantially Equivalent | |
| K130236 | RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 | JJS | Substantially Equivalent | |
| K120326 | AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE | JHX | Substantially Equivalent | |
| K122729 | ABL90 FLEX | CHL | Substantially Equivalent | |
| K122642 | ABL90 FLEX | CHL | Substantially Equivalent | |
| K120197 | ABL90 FLEX | CHL | Substantially Equivalent | |
| K112161 | AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.. | KHO | Substantially Equivalent | |
| K111897 | ABL90 | CHL | Substantially Equivalent | |
| K110416 | ABL835 FLEX ANALYZER WITH PLEURAL PH | CHL | Substantially Equivalent | |
| K100777 | ABL837 FLEX ANALYZER | CHL | Substantially Equivalent | |
| K092686 | ABL90 FLEX SERIES | CEM | Substantially Equivalent | |
| K093154 | TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM | LKD | Substantially Equivalent | |
| K051968 | ABL8X7 FLEX | CGL | Substantially Equivalent | |
| K051928 | AUTOCHECK6+ | JJY | Substantially Equivalent | |
| K050869 | MODIFICATION TO ABL800 FLEX | CIG | Substantially Equivalent | |
| K043218 | ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX | CHL | Substantially Equivalent | |
| K043143 | SAFEPICO | JKA | Substantially Equivalent | |
| K043003 | TCM40 MONITORING SYSTEM | LKD | Substantially Equivalent | |
| K041874 | ABL800 FLEX | CHL | Substantially Equivalent | |
| K001866 | TCM400 | LPP | Substantially Equivalent | |
| K002290 | ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) | CHL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002807968 | 3002807968 | RADIOMETER MEDICAL APS | AAKANDEVEJ 21, BROENSHOEJ Hovedstaden 2700 DK | 2026 | and 16 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHPAcid, Lactic, Enzymatic Method
- GHSAssay, Carboxyhemoglobin
- KQIAssay, Fetal Hemoglobin
- MQMBilirubin (Total And Unbound) In The Neonate Test System
- JIXCalibrator, Multi-Analyte Mixture
- JJSControls For Blood-Gases, (Assayed And Unassayed)
- CIGDiazo Colorimetry, Bilirubin
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- CGLElectrode, Ion Based, Enzymatic, Creatinine
- JFPElectrode, Ion Specific, Calcium
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CGZElectrode, Ion-Specific, Chloride
- KHOFluorometer, For Clinical Use
- JHXFluorometric Method, Cpk Or Isoenzymes
- CGAGlucose Oxidase, Glucose
- GKFInstrument, Hematocrit, Automated
- OUGMedical Device Data System
- LKDMonitor, Carbon-Dioxide, Cutaneous
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
- LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- DQAOximeter
- DPZOximeter, Ear
- MEGSyringe, Antistick
- GKRSystem, Hemoglobin, Automated
- GIOTube, Collection, Capillary Blood
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1659-2025 | Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092 The Radiometer ABL90 Series is a portable, automated analyzer for use in the laboratory environment, near patients or point-of-care settings. | ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even if a restart occurs, any sample being processed at that time will be lost, potential to lead to delay in test results. | Class II | Open, Classified | |
| Z-2426-2024 | ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) " In vitro testing of samples of expired air for the parameters pO2 and pCO2 " In vitro testing of pleura samples for the pH parameter. | Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples. | Class II | Open, Classified | |
| Z-1394-2023 | AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use. | Due to potential software issue that may result in patient mix-up information. | Class II | Open, Classified | |
| Z-1321-2022 | ABL800 Flex Analyzer Model Numbers 393-800 and 393-801 | There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+. | Class II | Open, Classified | |
| Z-1115-2022 | Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE | Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product. | Class II | Open, Classified | |
| Z-1858-2021 | E3800 PC Units (spare parts) | Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. | Class II | Open, Classified | |
| Z-1857-2021 | Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part. | Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. | Class II | Open, Classified | |
| Z-1856-2021 | Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part. | Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. | Class II | Open, Classified | |
| Z-1683-2021 | PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for collection of arterial samples for pH, blood gas, oximetry, electrolyte and metabolite analysis. Model Number/Product Description: 956-518 PICO70 w/o needle; 956-519 PICO70 w/o needle; 956-522 PICO70 22G x 25 mm; 956-525 PICO70 22G x 32 mm; 956-529 PICO70 23G x 16 mm; 956-533 PICO70 23G x 25 mm; 956-534 PICO70 23G x 32 mm; 956-547 PICO70 25G x 16 mm; | Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to the sterile barrier system for the product. During internal stress testing on PICO70 Arterial Blood Samplers a breach in the sterile barrier system was observed in one sample. Risk for the patient: The described error is considered to have a remote possibility of resulting in bacterial bloodstream infection. The bloodstream infection may be asymptomatic but may also progress to sepsis or life-threatening septic shock. Immunosuppressed patients are at particular risk. Due to issues (breaches) with the sterile barrier system for the Arterial Blood Sampler. | Class II | Terminated | |
| Z-2494-2020 | Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available as ABL837. The FlexQ module is optional and can be added to all models and configurations. | Potential risk of patient mix-up on analyzers due to software issues. | Class II | Terminated | |
| Z-2493-2020 | Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and ABL800Basic. The FlexQ module is optional and can be added to all models and configurations. | Potential risk of patient mix-up on analyzers due to software issues. | Class II | Terminated | |
| Z-2468-2020 | ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. | Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accession number. Misinterpretation of a barcode, including e.g. patient ID or accession number, may result in patient mix up and/or delayed medical treatment. | Class II | Terminated | |
| Z-2467-2020 | ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. | Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accession number. Misinterpretation of a barcode, including e.g. patient ID or accession number, may result in patient mix up and/or delayed medical treatment. | Class II | Terminated | |
| Z-2249-2020 | safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1 | The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples. | Class II | Terminated | |
| Z-2248-2020 | safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1 | The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples. | Class II | Terminated | |
| Z-2247-2020 | safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1 | The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples. | Class II | Terminated | |
| Z-1684-2020 | ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) In vitro testing of samples of expired air for the parameters pO2 and pCO2 In vitro testing of pleura samples for the pH parameter.0693938004 and 393-801/05700693938011 - Product Usage: | Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ID or accession number. The issue is related to barcode types not using a check digit. This could result in patient mixup or loss of sample resulting in delayed medical treatment | Class II | Terminated | |
| Z-1836-2020 | ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004 | Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function. | Class II | Open, Classified | |
| Z-1755-2020 | TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Usage: It is indicated for use on pediatrics and adults. | Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming non responsive and beeping. This may result in delayed patient monitoring as well as potentially compromise the product performance. | Class II | Terminated | |
| Z-1761-2020 | ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. | The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment. | Class II | Terminated | |
| Z-1760-2020 | ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. | The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment. | Class II | Terminated | |
| Z-2139-2020 | ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. | The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted through the sample. This will lead to a perturbed and non-linear absorbance spectrum which results in measurement errors. | Class II | Terminated | |
| Z-2138-2020 | ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. | The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted through the sample. This will lead to a perturbed and non-linear absorbance spectrum which results in measurement errors. | Class II | Terminated | |
| Z-0864-2020 | AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles. | The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some third-party devices. The error may lead to serious adverse health consequences for the patient caused by patient data mix-up. | Class II | Terminated | |
| Z-1582-2018 | AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets the user send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use. | There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain