Z-2494-2020Class II

Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011...

Name: Z-2494-2020 Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011...
Creator: Radiometer Medical ApS
Published: 2020-05-26
License: https://open.fda.gov/license/

Radiometer Medical ApS / initiated 2020-05-26 / Terminated / root cause: software

FDA source

Radiometer Medical ApS began a recall of 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... on 2020-05-26. FDA classified it as Class II and gives the reason as "Potential risk of patient mix-up on analyzers due to software issues". 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-2494-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-26
Posted: 2020-07-04
Terminated: 2023-02-08
Recalling firm: Radiometer Medical ApS
Product: 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.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Potential risk of patient mix-up on analyzers due to software issues.
Root cause tag: software
FDA root cause: Software design
Action: On 05/26/2020, the firm sent an Urgent: Medical Device Recall letter via email to all consignees; additionally the firm will send a hard copy letter FedEx 2nd day with tracking and proof of delivery.
Quantity in commerce: 3,899 units
Distribution: US - 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 and WY. OUS - Australia, Austria, Canada, Czech Republic, China, Croatia, Denmark, France, Finland, Germany, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom
Product codes and lots: Software versions 6.19 and below.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2494-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2493-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-04
Z-2494-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-04

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)