Reported Jun 10, 2020 · Terminated
Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210) for use…
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?
- Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine
- REF 33830 (UDI15099590227210) for use with the Access
- Family of Immunoassay Systems including
Access 2UniCel DxI 600UniCel DxI 800UniCel DxC 600iUniCel DxC 660iUniCel DxC 680iUniCel DxC 860iand UniCel DxC 880i systems
- Lot codes and dates
- Catalog Number33830; all lots
- Amount recalled
- 238,862
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.
This product could cause temporary or reversible health problems — stop using it.
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