Ortho Clinical VITROS Calcium Reagent Recalled for Potential Storage Exposure
Ortho Clinical Diagnostics' VITROS Calcium reagent (300-pack) is being recalled due to transit delays from severe thunderstorms that may have exposed the product to temperatures outside recommended storage conditions, potentially affecting test accuracy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product—incorrect or delayed test results from a diagnostic reagent could affect patient care decisions. No illnesses or injuries have been reported, placing it in the Score 3 category per the rubric.
Plain-English summary
Ortho Clinical Diagnostics Inc is recalling VITROS Calcium (L-SEQUESTER) reagent (300-pack) due to potential exposure to improper storage conditions during transit.
During shipment, severe thunderstorms caused transit delays that may have resulted in the products being stored outside the manufacturer's recommended labeled storage conditions.
Improper storage could increase the probability of incorrect test results or delayed test results in clinical laboratory testing. No illnesses or injuries have been reported.
The recalled product was distributed nationwide in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. Users who received this product should verify storage conditions and contact Ortho Clinical Diagnostics or their distributor with questions.
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
- incorrect-test-results
- delayed-test-results
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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