CLASS II Device recall · Reported 20 Dec 2017 · FDA Enforcement Report

ABL800 analyzer with Flexq module recalled by Radiometer America

Radiometer America is recalling ABL800 analyzer with Flexq module, distributed nationwide in the US. The recall was initiated on 24 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers

Quantity recalled1,749 analyzers

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0231-2018
FDA event ID: 78445
Recalling firm: Radiometer America, Brea, CA
Classification: Class II
Status: Terminated
Recall initiated: 24 Oct 2017
FDA classified: 8 Dec 2017
Reported: 20 Dec 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

24 Oct 2017	Recall initiated by company
8 Dec 2017	Classified by FDA	+45 days
20 Dec 2017	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer.

Product as listed by the FDA

ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters 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. It is also used for in vitro testing of pleura samples for the pH parameter

Where it was distributed

USA (nationwide) to: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, 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, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. Distributed internationally to Canada.

Nationwide Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Is ABL800 analyzer with Flexq module recalled?

Yes. Radiometer America recalled ABL800 analyzer with Flexq module on 24 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-0231-2018.

Why was it recalled?

Which lots are affected?

All serial numbers

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Radiometer America

All 24

Reported	Class	Recall	Company	Reason	Where
28 Aug 2019Device	CLASS II	ABL90 FLEX Analyzer recalled by Radiometer America	Radiometer America	Device Malfunction	36 states
13 Feb 2019Device	CLASS II	ABL800 FLEX with Crea recalled by Radiometer America	Radiometer America	Other	31 states
2 Jan 2019Device	CLASS II	ABL800 analyzer recalled by Radiometer America	Radiometer America	Device Malfunction	Nationwide
10 Oct 2018Device	CLASS II	ABL90 FLEX analyzers recalled by Radiometer America	Radiometer America	Device Malfunction	Nationwide
11 Oct 2017Device	CLASS II	AutoCheck5+, Level 2, specifically designed recalled	Radiometer America	Device Malfunction	Nationwide

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