Ortho Clinical Diagnostics Total Bili-Alkp XT Reagent Recall
Mckesson Medical-Surgical is recalling Ortho Clinical Diagnostics Total Bili-Alkp XT (L-Sequester) reagent due to cold chain storage failures during transit caused by severe thunderstorms, which may result in incorrect or delayed test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 for a medical device with a storage/handling failure. No illnesses or injuries have been reported; the hazard is potential test inaccuracy. The source text does not describe reported harm, making this a precautionary recall that fits the Moderate category.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling Ortho Clinical Diagnostics Inc Total Bili-Alkp XT (L-Sequester) (300/PK) Reagent (Catalog No. 6844296; GTIN: 10758750031801; Order No. 46033333) nationwide across the states of Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
The recall was initiated because certain cold chain products experienced transit delays during severe thunderstorms. These products may have been stored outside recommended labeled storage conditions as a result. This storage failure could increase the probability of an incorrect test result or a delayed test result.
Customers who have received affected units should contact their supplier or Mckesson Medical-Surgical for further instructions regarding the product.
The recalled product
- Product
- ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 600
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
Part of a larger recall action
This product is one of 32 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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