Reported Mar 1, 2023 · Ongoing
Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum…
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?
- Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells
- Siemens Material Number (SMN)10995573
- Lot codes and dates
4 of 4 products
Products covered by this recall # Barcodes Product as published 1 00630414598970(01)00630414598970(10)15307337(17)20230320 2 00630414598970(01)00630414598970(10)27948339(17)20230529 3 00630414598970(01)00630414598970(10)41142343(17)20230630 4 00630414598970(01)00630414598970(10)62968345(17)20230726. Lot Numbers: 15307337, 27948339, 41142343, 62968345 and higher. All current and future lots of the ADVIA Centaur Folate assay until the Instructions for Use are updated - Amount recalled
- 9,272 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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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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