Ortho Clinical Diagnostics Vitros Calcium Reagent Recalled Due to Storage Conditions
Ortho Clinical Diagnostics Vitros Calcium (L-Sequester) reagent is being recalled because transit delays caused by severe thunderstorms may have stored products outside recommended cold chain conditions, potentially leading to incorrect or delayed test results.
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: This is an FDA Class II recall involving a diagnostic reagent with potential for incorrect or delayed test results due to storage condition failure. No illnesses or injuries are reported, and the hazard is a reduction in test reliability rather than direct patient harm. Class II recalls without reported adverse events typically score 2 under the rubric.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling Ortho Clinical Diagnostics Vitros Calcium (L-Sequester) reagent (Catalog No. 1450261, 300-pack units) due to cold chain failures during transit. Severe thunderstorms caused transit delays that may have resulted in products being stored outside the manufacturer's recommended labeled storage conditions.
This storage condition failure could increase the probability of an incorrect test result or a delayed test result. The affected product was distributed nationwide to customers in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
Customers who have received affected product should contact their supplier or Mckesson Medical-Surgical Inc. for instructions regarding return or replacement.
The recalled product
- Product
- ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- improper-storage
- test-result-inaccuracy
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)
- Catalog No. 1450261
- GTIN: 10758750009114
- Order No. 46117007.
Distribution
Distributed nationwide across the United States.
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