Z-0705-2007

ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27

Name: Z-0705-2007 ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27
Creator: Radiometer America Inc
Published: 2007-01-16
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2007-01-16 / Terminated / root cause: labeling and UDI

FDA source

Radiometer America Inc began a recall of ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27 on 2007-01-16. The reason FDA records is "In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific patient is pre-registered in the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0705-2007
Status: Terminated
Initiated: 2007-01-16
Posted: 2007-04-06
Terminated: 2012-05-08
Recalling firm: Radiometer America, Inc
Product: ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific patient is pre-registered in the analyzer by scanning a barcode.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Radiometer America issued a recall letter to their U.S. customers dated 1/16/2007. The letter informs the customers of this software anomaly and the conditions underwhich analyzer results can be stored with incorrect Patient Demographics. The letter goes on to inform the customers that a Radiometer Service Representative will be visiting each customer location shortly in order to upgrade the affected software. In the meantime, the letter recommends that the customer(s) not pre-register their samples. The letter is accompanied by an attached FAX FORM which the customer is asked to sign and complete in order to verify receipt of the recall letter and to fax back to the recalling firm.
Quantity in commerce: 64 in U.S. & 1,281 to foreign accounts
Distribution: Worldwide Distribution-USA including states of NY, KS, SD, OH, TX, KY, NC, IL, MO, AL, UT, CO, CA, NM, and MI and Country of Denmark
Product codes and lots: There are no specific lot codes. (devices equipped with software version 5.2 to 5.27)

Product code CHL

K043218Class IIAbl800 Flex with Flexq Module, Model Abl8xxRadiometer Medical Aps / cleared 2005-05-10

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)