CLASS II Device recall · Reported 11 Oct 2017 · FDA Enforcement Report

AutoCheck5+, Level 2, specifically designed recalled

Radiometer America is recalling AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers, distributed nationwide in the US. The recall was initiated on 7 Sep 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesS7745 Lot R0698

Quantity recalled1669 Boxes

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-3237-2017
FDA event ID: 78097
Recalling firm: Radiometer America, Brea, CA
Classification: Class II
Status: Terminated
Recall initiated: 7 Sep 2017
FDA classified: 29 Sep 2017
Reported: 11 Oct 2017
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

7 Sep 2017	Recall initiated by company
29 Sep 2017	Classified by FDA	+22 days
11 Oct 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

Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a result close to or just outside of the low end of the control range. (4.92 5.85 kPa or 36.9 46.9 mmHg) " pO2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kPa (104-107 mmHg)

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

AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers

Where it was distributed

Worldwide Distribution - US (nationwide) Internationally to Canada, Netherlands, China, Czech Republic, Denmark, Germany, Spain France, Hungary, India, Denmark, Tokyo, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, and Finland.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

S7745 Lot R0698

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 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
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	CA
20 Dec 2017Device	CLASS II	ABL800 analyzer with Flexq module recalled by Radiometer America	Radiometer America	Other	Nationwide

Other Test Kits & Diagnostics recalls

All 2,661

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	McKesson Consult hCG Urine Cassette recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
7 Oct 2026Device	CLASS II	Systems/units containing affected recalled	Beckman Coulter Mishima K.K	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
30 Sep 2026Device	CLASS II	Vitek 2 Ast-N461 Test Kit, Gram Negative Susceptibility recalled	Biomerieux	Other	MO
23 Sep 2026Device	CLASS II	DASH Rapid PCR Instrument recalled by Nuclein	Nuclein	Device Malfunction	Nationwide