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.
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 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
- Hazard
- improper-storage
- test-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.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22