CLASS II Device recall · Reported 15 Aug 2012 · FDA Enforcement Report

ABL90 FLEX recalled by Radiometer America

Radiometer America is recalling ABL90 FLEX, distributed nationwide in the US. The recall was initiated on 5 Jul 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: 393-090, all production runs, 393-090R0026N0010 to 393-090R0179N010

Quantity recalled1427 ABL 90 Instruments

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-2164-2012
FDA event ID: 62503
Recalling firm: Radiometer America, Westlake, OH
Classification: Class II
Status: Terminated
Recall initiated: 5 Jul 2012
FDA classified: 8 Aug 2012
Reported: 15 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

5 Jul 2012	Recall initiated by company
8 Aug 2012	Classified by FDA	+34 days
15 Aug 2012	Published in enforcement report	+7 days

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

Reason for recall

A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5, any results in the queue will be mixed up when the instrument transmits t

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

ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.

Where it was distributed

Worldwide distribution: USA (nationwide) including the states of AK, AL, AR, AZ, BM, 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, VT, WA, WI, WV, and WY, and the countries of Canada, Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech republic, Denmark, Ecuador, Egypt, Eritrea, Estonia, Finland, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Malta, Mauritius, Mexico, Moldova, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Puerto Rico, Qatar, Republic of Korea, Romania, Russia, Saudi Arabia, Switzerland, Singapore, Slovenia, South Africa, Spain, Sweden Syria, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Yugoslavia, and Zimbabwe.

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

Questions about this recall

Why was it recalled?

Which lots are affected?

Part Number: 393-090, all production runs, 393-090R0026N0010 to 393-090R0179N010

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.

Other products in this recall event

1 other product · FDA event 62503

Reported	Class	Recall	Company	Reason	Where
15 Aug 2012	CLASS II	The ABL recalled by Radiometer America	Radiometer America	Device Malfunction	Nationwide

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

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