Lipid Profile Test Cassettes from Abbott Recalled Due to Cold Chain Exposure
McKesson Medical-Surgical is recalling Abbott Cholestec LDX Lipid Profile test cassettes that were exposed to temperatures outside recommended storage conditions during transit delays. This could result in 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: This is an FDA Class II medical device recall where documented storage-temperature exposure occurred that could result in incorrect diagnostic test results. No illnesses or injuries have been reported. The High severity is warranted because the product directly affects medical decision-making, though the actual patient harm remains theoretical.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Abbott Rapid DX Cholestec LDX Lipid Profile test cassettes (Catalog No. 97989, GTIN 893038002913). These diagnostic devices are used to measure cholesterol and lipid levels in clinical settings.
The cassettes were exposed to temperatures outside the manufacturer's recommended storage conditions during transit delays caused by severe thunderstorms. This environmental exposure could increase the probability of incorrect test results or delayed test processing, potentially affecting the accuracy of patient lipid measurements and clinical decision-making.
The affected cassettes were distributed nationwide to healthcare facilities in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. Healthcare providers and clinical laboratories using these cassettes should discontinue use and contact McKesson Medical-Surgical Inc. or Abbott Rapid DX for guidance on replacement, refund, or proper disposal.
The recalled product
- Product
- ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- storage-temperature-failure
- inaccurate-test-result
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. 97989
- GTIN: 893038002913
- Order No. 46115470.
Distribution
Distributed nationwide across the United States.
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