Reported Oct 11, 2023 · Ongoing
ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
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 Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
- Lot codes and dates
- (6
- x 350 tests) UDI-DI
00630414561974(7
- x 145 tests) UDI-DI00630414513157
- Lot Numbers612584 625096 612579 625091 635826 635821
- Amount recalled
- 4966 reagents
Where it was sold
- Nationwide
Why it was recalled
There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias will vary wedge to wedge.
This product could cause temporary or reversible health problems — stop using it.
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