ORTHO CLINICAL DIAGNOSTICS VITROS Phosphorus Reagent Recall
ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS reagent units may have been stored outside recommended cold chain conditions due to severe thunderstorms, risking 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 a Class II medical device recall involving storage condition excursion of a clinical laboratory reagent. The source text explicitly indicates no reported illnesses or incorrect test results have occurred; the risk is theoretical and relates to potential product performance degradation due to temperature exposure during transit.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) clinical laboratory reagent. The product was distributed nationwide to AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN, and WV. Certain units experienced transit delays during severe thunderstorms, which may have caused them to be stored outside the manufacturer's recommended labeled storage conditions.
When stored outside the recommended temperature range, the reagent may produce incorrect test results or delayed test results. This failure could affect the accuracy of phosphorus measurements in patient samples tested with affected reagent units.
Customers in possession of affected units should discontinue use and contact Mckesson Medical-Surgical Inc. or Ortho Clinical Diagnostics for guidance. The affected products are identified by Catalog No. 1513209; GTIN: 10758750009220; and Order No. 46094482.
The recalled product
- Product
- ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- storage-condition-excursion
- incorrect-test-result
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. 1513209
- GTIN: 10758750009220
- Order No. 46094482.
Distribution
Distributed nationwide across the United States.
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