Abbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue
Abbott Diagnostics ARC Carbon Dioxide 6x5mL B Calibrator units experienced transit delays due to severe thunderstorms, potentially exposing products to storage conditions outside the manufacturer's recommendations. This may increase the risk of 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 involving a diagnostic device with a potential quality issue related to storage conditions. No illnesses or injuries are reported in the source text; the hazard is a theoretical risk of incorrect or delayed test results due to improper storage exposure.
Plain-English summary
Abbott Diagnostics ARC Carbon Dioxide 6x5mL B Calibrator (Catalog No. 01E6403, GTIN: 380740161378, Order No. 46043577) is being recalled due to cold chain storage issues during distribution.
Certain units experienced transit delays caused by severe thunderstorms, which may have resulted in the products being stored outside the manufacturer's labeled storage conditions. This storage failure could increase the probability of an incorrect test result or a delayed test result.
The product was distributed nationwide in the states of Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. The recalling firm is McKesson Medical-Surgical Inc. Corporate Office.
Customers who have received this product should verify that it was stored and transported under the proper conditions. If there are concerns about product integrity or test performance, contact the recalling firm or consult the manufacturer's guidance on handling and storage.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 1
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. 01E6403
- GTIN: 380740161378
- Order No. 46043577.
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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