Ortho-Clinical Diagnostics Recalls VITROS Vitamin B12 Reagent Packs
Ortho-Clinical Diagnostics is recalling VITROS Vitamin B12 Reagent Packs due to a potential for increased calibration failures.
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 is a functional defect (calibration failures) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 6,630 units of VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489. The affected lots are 2601, 2610, and 2620. These products are used for the quantitative measurement of vitamin B12 in human serum and plasma to aid in the differential diagnosis of anemia.
The recall was initiated because the reagent packs exhibit the potential for an increased frequency of calibration failures. The products were distributed nationwide in the United States and internationally to Belgium, Bermuda, Brazil, Canada, Chile, Columbia, Denmark, France, Germany, India, Italy, Portugal, Spain, and the UK.
Healthcare facilities and laboratories should stop using the affected reagent packs and contact Ortho-Clinical Diagnostics for instructions on how to return or dispose of the product.
The recalled product
- Product
- VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS…
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- Affected units
- 6,630
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)
- Lot 2601
- 2610
- 2620
Distribution
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