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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- 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
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics
See all →- ModerateSiemens BC Thrombin Reagent Kit Recall for Unexpected Prolonged Results
FDA (Devices) · 2018-03-07
- ModerateSiemens IMMULITE 1000 Cortisol Assay Recalled for Positive Bias
FDA (Devices) · 2014-10-29
- ModerateSiemens Recalls ADVIA Centaur XP Immunoassay Systems Due to Data Error
FDA (Devices) · 2014-10-08
- ModerateSiemens Recalls ADVIA Centaur Immunoassay Systems Due to Data Error
FDA (Devices) · 2014-10-08
- ModerateSiemens ADVIA Centaur Immunoassay System Field Correction for Sample Rack Loading
FDA (Devices) · 2014-09-24
Same hazard · performance failure
See all →- ModerateAmerican Contract System Convenience Kits Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract System Convenience Kit Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract System Convenience Kit Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract Systems Recalls Convenience Kits with Non-Conforming Catheters
FDA (Devices) · 2026-09-02
- ModerateRemel Neisseria meningitidis Gp C In Vitro Diagnostics Recall
FDA (Devices) · 2026-08-19
Similar recalls
- ModerateSiemens IMMULITE 2000 Folic Acid Assay Recalled for Biotin Interference
FDA (Devices) · 2018-05-16
- ModerateSiemens IMMULITE Androstenedione Assay Recalled for Over-Recovery
FDA (Devices) · 2014-05-07
- ModerateSiemens IMMULITE 1000 Cortisol Assay Recalled for Positive Bias
FDA (Devices) · 2014-10-29
- ModerateSiemens CMV IgM Assay Recalled for Increased Imprecision
FDA (Devices) · 2016-11-02
- HighSiemens Recalls Rubella IgM Assay Kits Due to False Positive Results
FDA (Devices) · 2016-10-19
- LowSiemens IMMULITE Calcitonin Control Module Recalled for Typographical Error
FDA (Devices) · 2014-11-19