Sendx Medical, Inc.
Carlsbad, CA, US
Sendx Medical, Inc. appears in FDA device records in Carlsbad, CA. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 7 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Sendx Medical, Inc. between 1997 and 2015. The busiest year on record is 2015, with 2. The most recent is 2015, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 2000 | 1 |
| 2005 | 1 |
| 2008 | 1 |
| 2015 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K151639 | ABL80 FLEX and ABL80 FLEX CO-OX | CGA | Substantially Equivalent | |
| K151856 | ABL80 FLEX CO-OX with AQURE connectivity | CHL | Substantially Equivalent | |
| K080370 | ABL 80 CO-OX SYSTEM | CHL | Substantially Equivalent | |
| K051804 | ABL80 FLEX ANALYZER | CHL | Substantially Equivalent | |
| K994346 | ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM | CHL | Substantially Equivalent | |
| K973742 | SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM | CGZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2304-2012 | ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists, nurses, physicians and therapists. They are intended for use in a laboratory environment, near patient or point-of-care setting. | The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition. | Class II | Terminated | |
| Z-1384-2012 | SenDx Medical Inc ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite System The ABL80 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and hematocrit in whole blood. The ABL80 FLEX system is 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 product can cause the analyzer to report values outside the published performance specifications for pH, pCO2, cNa+, cK+, cCa2+ and cCl-. | Terminated | ||
| Z-0195-2013 | ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is 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 recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters. | Class II | Terminated | |
| Z-0150-2010 | ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is 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. | Inverness have recently become aware of a potential error contained in V1.30 and V1.31 software for the ABL 80 CO-OX platform. The error can occur if the analyzer is set to automatically upload patient records to Radiance or an HIS/LIS system. This can result in the reporting of incorrect results for one or more CO-OX derived parameters. Incorrect results can be displayed on the screen and the | Terminated | ||
| Z-1173-2007 | ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company | Error in the Ca12 calibration value for pCO2 recorded in the cal pack barcode for lot 17323. This error will result in falsely elevated pCO2 results at the high end of the measuring range. | Terminated | ||
| Z-1201-2007 | ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863 | The ABL8O FLEX software version 1.10 contains errors in the derived parameter calculation for cBase(B,ox) and cBase(Ecf,ox). These incorrect calculations result in a mild to moderate lowering of the base excess value, the severity depending on the concentration of hemoglobin and the oxygen saturation in the sample. Elevated hemoglobin concentrations have the greatest impact on this calculation err | Terminated | ||
| Z-1196-2007 | ABL80 FLEX Analyzer, Model #393-839 | There have been reported experiences where waste fluids have sprayed out from the waste drain at the front of the ABL80 analyzer when excessive pressure builds within the waste line. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain