Ortho Clinical Diagnostics Vancomycin Reagent Cold Chain Recall
Mckesson Medical-Surgical is recalling Ortho Clinical Diagnostics Vancomycin reagent (Catalog No. 6801709) distributed nationwide due to transit delays and severe thunderstorms that may have caused storage outside recommended conditions, risking incorrect 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: The source text states the recall concerns a medical device (reagent) where improper storage may result in incorrect or delayed test results, creating a risk of harm. No illnesses or injuries are reported, but the potential for clinical harm from diagnostic error is significant and inherent to the product's function.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling Ortho Clinical Diagnostics Inc Vancomycin (300/BX) reagent, Catalog No. 6801709. The product was distributed nationwide to Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
During transit, severe thunderstorms caused delays that may have resulted in the products being stored outside their recommended labeled storage conditions. This storage failure could increase the probability of an incorrect test result or a delayed test result.
If you have received this product, contact Mckesson Medical-Surgical Inc. Corporate Office with your order information. Do not use affected units until you have confirmed they were stored within the proper temperature range.
The recalled product
- Product
- ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 300
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
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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