CLASS II Device recall · Reported 29 Aug 2012 · FDA Enforcement Report

UniCel DxI 800 Access Immunoassay Systems, Part Numbers recalled

Beckman Coulter is recalling UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100, distributed nationwide in the US. The recall was initiated on 13 Oct 2011 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285.

Quantity recalled2442 units total (784 units in US)

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-2257-2012
FDA event ID: 62706
Recalling firm: Beckman Coulter, Brea, CA
Classification: Class II
Status: Terminated
Recall initiated: 13 Oct 2011
FDA classified: 23 Aug 2012
Reported: 29 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

13 Oct 2011	Recall initiated by company
23 Aug 2012	Classified by FDA	+315 days
29 Aug 2012	Published in enforcement report	+6 days

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

Reason for recall

The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

Where it was distributed

Worldwide distribution: USA (nationwide) and countries of: Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea,Republic of; Kuwait, Liechtenstein, Malaysia, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.

Nationwide Puerto Rico

Questions about this recall

Is UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100 recalled?

Yes. Beckman Coulter recalled UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100 on 13 Oct 2011. The recall is Class II and its status is Terminated. Recall number Z-2257-2012.

Why was it recalled?

The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results.

Which lots are affected?

Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285.

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.

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