Reported May 16, 2018 · Terminated
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
Siemens Healthcare Diagnostics, 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: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
- Lot codes and dates
- Anti HBc, Anti HBc (IMMULITE 2000/IMMULITE 2000
- XPi L2KHC2 (D)) Lot codesAnti HBcM # 579 580 581 D579 D580 D581 ***Added 9/11/20*** D602
- Amount recalled
- N/A
This recall covers 44 products
The agency filed one notice per product. You are reading one of them; the other 43 are below.
31 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
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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