Reported Mar 1, 2023 · Ongoing
ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human…
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. · 333 Coney St · East Walpole, MA · 02032-1516
Is this the product you have?
- ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells
- Siemens Material Number (SMN)10310308
- Lot codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 00630414204192(01)00630414204192(10)16275336(17)20230320 2 00630414204192(01)00630414204192(10)21333336(17)20230320 3 00630414204192(01)00630414204192(10)22318336(17)20230320 4 00630414204192(01)00630414204192(10)23066336(17)20230320 5 00630414204192(01)00630414204192(10)27947338(17)20230529 6 00630414204192(01)00630414204192(10)62967344(17)20230726. Lot Numbers: 16275336, 21333336, 22318336, 23066336, 27947338, 62967344 and higher. Affects all current and future lots of the ADVIA Centaur Folate assay until the Instructions for Use are updated - Amount recalled
- 14,669 kits
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
This product could cause temporary or reversible health problems — stop using it.
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