Ortho Clinical Diagnostics Diluent Pack Recall Due to Cold Chain Failure
McKesso Medical-Surgical Inc. is recalling Ortho Clinical Diagnostics FS Diluent Packs due to transit delays from severe thunderstorms that may have caused improper storage conditions. The affected products could produce 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 diagnostic reagent storage failure. The source text does not report actual illnesses, injuries, or confirmed test failures—only a potential risk of incorrect or delayed results. Class II recalls with no reported adverse health outcomes typically score 2 under the rubric.
Plain-English summary
McKesso Medical-Surgical Inc. is recalling Ortho Clinical Diagnostics FS (3PK/BX) Diluent Packs (Catalog No. 6801754; GTIN: 10758750007004; Order No. 46084922) distributed nationwide in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. The recall was initiated due to transit delays of the diluent packs caused by severe thunderstorms, which resulted in the products being stored outside their recommended labeled storage conditions.
Storage conditions outside those recommended on the product label could increase the probability of an incorrect test result or a delayed test result. The FDA has classified this as a Class II recall. Affected facilities and healthcare providers should verify whether they received affected product and review their storage records during the recall period.
The recalled product
- Product
- ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- storage-condition-failure
- test-result-accuracy
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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