Reported Apr 10, 2019 · Ongoing
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line
- UniCel DxI 600 Catalog Numbers
A30260A71460A71461A92060
- Unicel DxI 800 Catalog Numbers
973100A71456A71457A84545A25288A25285
- Lot codes and dates
- Systems running software versions5.2, 5.3.0, 5.3.1. Serial #:
2,842 of 2,842 codes
605042605047605048605050606363606439901612901626605300605301605516900777605636606566606567606383606744606745605996606161606169606231606500606565606155606156606302606740606743604566604622604624604627604713606646606746604912604951606128606386606324605932606755603377604309605909604410605372604178604426604796604744602700603298603660603797603897605762604608606411
- Systems running software versions5.2, 5.3.0, 5.3.1. Serial #:
- Amount recalled
- 2842
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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