Reported May 16, 2018 · Terminated
ADVIA Centaur¿ Folate (FOL)
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?
- ADVIA Centaur¿ Folate (FOL)
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 Lot # 03460256 09302256 81236256 09294257 30152258 ADVIA Centaur Folate (100 Test) 2 Lot # 76793256 85114256 96368256 05299257 99361257 19045258 25443258 40856260 ADVIA Centaur Folate (500 test) 3 Lot # 73249256 76207256 85113256 00245257 00495257 03779257 05298257 99360257 19042258 19043258 19044258 31130258 36171260 - 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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