Siemens IMMULITE Folic Acid Kits Recalled for Potential Expiration Issues
Siemens Healthcare Diagnostics is recalling specific lots of IMMULITE Folic Acid kits due to a potential accelerated decline in counts that may cause failed adjustments before expiration.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential performance issue (failed adjustment) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics is recalling specific lots of IMMULITE/IMMULITE 1000 Systems FOL Folic Acid kits. The affected products are identified by Reference/Catalog Number LKFO1 (100 tests) and Siemens Material Number 10380902. The recall involves Kit Lots 335, 336, and 337.
The recall is being issued because of a potential for an accelerated decline in counts per second (CPS) for these three kit lots. This issue may lead to a failed adjustment before the labeled expiration date is reached. The product is an in vitro diagnostic (IVD) used for the quantitative measurement of folic acid in serum, heparinized plasma, or ascorbic acid-treated whole blood, serving as an aid in the clinical diagnosis and treatment of anemia.
The affected kits were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous international locations such as Argentina, Brazil, Canada, China, Germany, and the United Kingdom. Domestic distribution included 442 kits, while foreign distribution included 680 kits. Users of these kits should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- 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 quantit
- Manufacturer
- Siemens Healthcare Diagnostics
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Kit Lots 335
- 336
- and 337
Distribution
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