Vancomycin Reagent Recalled Due to Cold Chain Storage Failure
Mckesson is recalling ORTHO CLINICAL DIAGNOSTICS vancomycin reagent due to transit delays caused by severe thunderstorms that may have exposed products to improper storage conditions, potentially resulting in inaccurate or delayed 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 Class II medical device recall presents a theoretical risk of diagnostic error if vancomycin reagent has been compromised by improper storage conditions. No illnesses or test failures have been reported. The risk of inaccurate test results meets the rubric criterion for High severity.
Plain-English summary
ORTHO CLINICAL DIAGNOSTICS vancomycin reagent (300 units per box, Catalog No. 6801709, GTIN 10758750006731) distributed nationwide in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia is being recalled by Mckesson Medical-Surgical Inc.
The recall was initiated due to transit delays caused by severe thunderstorms that resulted in products being stored outside their labeled storage temperature requirements. This storage condition failure could increase the probability of incorrect test results or delayed test results, potentially affecting diagnostic accuracy.
Healthcare facilities and diagnostic laboratories that received affected vancomycin reagent can identify potentially affected units using catalog number 6801709 and order number 46093490. Inventory from affected shipments should be handled in accordance with facility quality control procedures and relevant regulatory guidance.
The recalled product
- Product
- ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- test-inaccuracy
- test-delay
- storage-failure
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. 6801709
- GTIN: 10758750006731
- Order No. 46093490.
Distribution
Distributed nationwide across the United States.
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