Abbott Rapid DX Diagnostic Control Recalled for Cold Chain Storage Failure
Abbott Rapid DX diagnostic control products were improperly stored during transit due to severe thunderstorms, which may cause 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 is an FDA Class II medical device quality control product with no reported illnesses or injuries. The risk that improper storage could compromise diagnostic test accuracy qualifies this as a risk-of-harm product without reported injury, meeting the criteria for High severity.
Plain-English summary
Abbott Rapid DX N America LLC Multi Analyte Level 1&2 250UL Chols Control has been recalled because products were stored outside their recommended labeled storage conditions due to transit delays caused by severe thunderstorms.
This is a quality control material used in diagnostic testing. Storage outside recommended conditions may compromise the integrity of the control material, potentially increasing the risk of inaccurate or delayed test results in clinical or laboratory diagnostics.
The recalled products were distributed nationwide in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. The affected products can be identified by Catalog No. 88773 and GTIN 893038002036.
Recipients of affected products should contact Mckesson Medical-Surgical Inc. for guidance on product replacement or return instructions.
The recalled product
- Product
- ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- improper-storage
- inaccurate-results
- delayed-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. 88773
- GTIN: 893038002036
- Order No. 46108009.
Distribution
Distributed nationwide across the United States.
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