Laboratory Diagnostic Reagent Recalled Due to Cold Chain Failure
A laboratory reagent was recalled because weather-related transit delays caused it to be stored outside recommended temperature conditions. This could result in incorrect or delayed diagnostic 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 qualifies as a risk-of-harm medical device where improper storage could affect diagnostic test accuracy. Although no illnesses or injuries have been reported and the hazard remains theoretical, the potential for incorrect laboratory results poses a clinical risk. FDA Class II classification combined with the unconfirmed nature of the hazard supports a High rating, which is the maximum for unconfirmed harms per the rubric.
Plain-English summary
Ortho Clinical Diagnostics Total Bili-ALKP XT (L-Sequester) laboratory reagent has been recalled due to storage condition failures during transit. Severe thunderstorms caused delays that resulted in certain units being stored outside the manufacturer's recommended labeled storage conditions.
The affected product is distributed nationwide in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia, with 600 units involved in this recall. This reagent is used in clinical laboratory testing.
When stored outside recommended conditions, the reagent's performance may be compromised. This increases the probability of incorrect test results or delayed test results, which could affect diagnostic accuracy and clinical decision-making. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- storage-failure
- temperature-deviation
- diagnostic-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. 6844296
- GTIN: 10758750031801
- Order No. 46033333.
Distribution
Distributed nationwide across the United States.
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