Ortho Clinical Diagnostics Diluent Pack Recall Due to Storage Conditions
Ortho Clinical Diagnostics diluent packs may have been stored outside recommended cold-chain conditions during transit due to severe thunderstorms. This could lead to incorrect or delayed test results.
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 Class II medical device recall for a risk-of-harm product used in clinical diagnostics. The failure to maintain proper storage conditions could result in incorrect or delayed test results, which directly affects patient care and diagnostic accuracy. No illnesses or injuries have been reported, so per the rubric this is High rather than Severe.
Plain-English summary
Ortho Clinical Diagnostics FS Diluent Pack 3 units are being recalled due to transit delays caused by severe thunderstorms. The severe weather prevented proper cold-chain storage during shipment, which may have caused products to be stored outside their labeled storage requirements.
When stored improperly, these diluent packs used in clinical diagnostics testing may produce incorrect test results or delayed test results. This could affect the accuracy of laboratory testing that relies on these diluents.
The affected products were distributed in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. The affected products carry Catalog No. 6801754, GTIN 10758750007004, and Order No. 46084922.
The recalled product
- Product
- ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- cold-chain-failure
- 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. 6801754
- GTIN: 10758750007004
- Order No. 46084922.
Distribution
Distributed nationwide across the United States.
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