Reported Mar 1, 2023 · Ongoing
ADVIA Centaur Folate 500 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 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells
- Siemens Material Number (SMN)10325366
- Lot codes and dates
7 of 7 products
Products covered by this recall # Barcodes Product as published 1 00630414450940(01)00630414450940(10)16276336 (17)20230320 2 00630414450940(01)00630414450940(10)21334336(17)20230320 3 00630414450940(01)00630414450940(10)22079336(17)20230320 4 00630414450940(01)00630414450940(10)27946338(17)20230529 5 00630414450940(01)00630414450940(10)41225342(17)20230630 6 00630414450940(01)00630414450940(10)62966344 (17)20230726 7 Lot Numbers: 16276336, 21334336, 22079336, 27946338, 41225342, 62966344 and higher. Affects all current and future lots of the ADVIA Centaur Folate assay assay until the Instructions for Use are updated. - Amount recalled
- 7,884 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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