CLASS II Device recall · Reported 2 Jan 2019 · FDA Enforcement Report

ABL800 analyzer recalled by Radiometer America

Radiometer America is recalling ABL800 analyzer, distributed nationwide in the US. The recall was initiated on 3 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 393-800 ABL800 Series w/o Creatinin (All serial numbers) for the following configurations: ABL800, ABL805, ABL810, ABL815, ABL820, ABL825, ABL830, and ABL835. Model 393-801 ABL800 Series with Creatinin (All serial numbers) for the following configurations: ABL817, ABL827, and ABL837.

Quantity recalled2,131 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-0682-2019
FDA event ID: 81547
Recalling firm: Radiometer America, Brea, CA
Classification: Class II
Status: Terminated
Recall initiated: 3 Jul 2018
FDA classified: 22 Dec 2018
Reported: 2 Jan 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

3 Jul 2018	Recall initiated by company
22 Dec 2018	Classified by FDA	+172 days
2 Jan 2019	Published in enforcement report	+11 days

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

Reason for recall

The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

ABL800 analyzer, model numbers 393-800 and 393-801.

Where it was distributed

Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Canada.

Nationwide

Questions about this recall

Why was it recalled?

The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.

Which lots are affected?

Model 393-800 ABL800 Series w/o Creatinin (All serial numbers) for the following configurations: ABL800, ABL805, ABL810, ABL815, ABL820, ABL825, ABL830, and ABL835. Model 393-801 ABL800 Series with Creatinin (All serial numbers) for the following configurations: ABL817, ABL827, and ABL837.

Where was it sold?

Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Canada.

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 26 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
10 Oct 2018Device	CLASS II	ABL90 FLEX analyzers recalled by Radiometer America	Radiometer America	Device Malfunction	CA
20 Dec 2017Device	CLASS II	ABL800 analyzer with Flexq module recalled by Radiometer America	Radiometer America	Other	Nationwide
11 Oct 2017Device	CLASS II	AutoCheck5+, Level 2, specifically designed recalled	Radiometer America	Device Malfunction	Nationwide

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