Z-1684-2020Class II

ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH...

Name: Z-1684-2020 ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH...
Creator: Radiometer Medical ApS
Published: 2020-03-10
License: https://open.fda.gov/license/

Radiometer Medical ApS / initiated 2020-03-10 / Terminated / root cause: software

FDA source

Radiometer Medical ApS began a recall of 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... on 2020-03-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1684-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-10
Posted: 2020-04-08
Terminated: 2022-10-31
Recalling firm: Radiometer Medical ApS
Product: 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:
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: 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
Root cause tag: software
FDA root cause: Software design
Action: On 3/10/2020, a "Urgent: medical Device Recall" letter was sent via email and FedEx to affected consignees. In addition to informing the consignee about the recall issue, the recall notification asked customers to take the following action: Check if your institution is using barcode types without a check digit, including e.g. patient ID or accession number, to be read on the ABL800. 1. If you use barcode types without a check digit, Radiometer recommends to either: - Enable the check digit on the barcode type currently used, or - Change type of barcode to one that includes a check digit, as this enables the barcode reader to validate the data read, and hence, to capture if the barcode has been misinterpreted and consequently to reject such data. 2. If you use barcode types with a check digit the barcode reader already validates the data read, and hence, captures if the barcode has been misinterpreted and consequently rejects such data. Hence, no action required. 3. If you do not use barcodes to be read by the ABL800, no action required. 4. Complete the Recall Response Form (last page of this letter) and submit to your Radiometer distributor. 5. If you have any questions, please contact us at 1-800-736-0600 option 1, Monday Friday 9am EST to 7pm EST. Solution provided by Radiometer Radiometer has released software version V6.19, which we will install on your analyzer, disregarding which barcode type is used, or no barcodes are used at all. The new software version scans the barcode three times (as opposed to once in previous versions). For barcode types without a check digit, this change may potentially reduce the risk of misinterpretation, if caused by the factors, which may add to the risk of misinterpretation, mentioned above.
Quantity in commerce: 3,656 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, BM, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and countries of Canada, China, Czech Republic, Denmark, Germany, Spain, France, Hungary, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland, Croatia, Russia, Norway.
Product codes and lots: Software versions below 6.19

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1684-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1684-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-08

Product code CHL

K041874Class IIAbl800 FlexRadiometer Medical Aps / cleared 2004-10-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)