Reported Jan 1, 2014 · Terminated
IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN)…
Siemens Healthcare Diagnostics
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 · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- Siemens Healthcare Diagnostics Products Ltd. An IVD for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.
- Lot codes and dates
Kit Lots 335336and 337
- Amount recalled
- Domestic: 442 kits; Foreign: 680 kits
Where it was sold
- Nationwide
- PR
Why it was recalled
potential for an accelerated decline in counts per second (CPS) for three IMMULITE/IMMULITE 1000 Folic Acid kit lots. This may lead to a failed adjustment before the labeled expiration date is reached.
This product could cause temporary or reversible health problems — stop using it.
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