Abbott Diagnostics Carbon Dioxide Calibrator Storage Condition Excursion
Abbott Diagnostics ARC Carbon Dioxide 6x5mL calibrators distributed to ten US states may have been exposed to temperatures outside recommended storage conditions during transit, potentially affecting diagnostic test result accuracy.
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: FDA Class II recall with no reported illnesses or injuries. The hazard involves potential compromise to calibrator accuracy due to storage condition excursion, but no actual adverse outcomes have been documented. This is a precautionary recall addressing storage-related device integrity issues.
Plain-English summary
Abbott Diagnostics ARC Carbon Dioxide 6x5mL B Calibrators (Catalog No. 01E6403, GTIN 380740161378) have been recalled by McKesson Medical-Surgical Inc. due to potential storage condition excursions during transit.
Severe thunderstorms caused transit delays that resulted in certain calibrator units being stored outside their recommended labeled storage conditions. This storage excursion could increase the probability of incorrect or delayed test results when these calibrators are used.
The recalled calibrators were distributed nationwide to Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
Consumers and healthcare providers should discontinue use of these units and contact their supplier or McKesson Medical-Surgical Inc. for replacement or instructions.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-excursion
- inaccurate-results
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
Distributed nationwide across the United States.
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