Abbott Rapid DX Cholestec LDX Lipid Profile Test Cassettes Recall
Abbott Rapid DX Cholestec LDX Lipid Profile test cassettes are being recalled because transit delays caused by severe thunderstorms may have exposed products to storage temperatures outside recommended conditions, which could result in 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 precautionary measure due to potential storage-condition deviations. No illnesses or incorrect test results have been reported; the risk is theoretical based on potential for compromised test accuracy if cassettes were exposed to out-of-specification temperatures.
Plain-English summary
Abbott Rapid DX N America LLC is recalling Cholestec LDX Lipid Profile test cassettes (Catalog No. 97989, GTIN 893038002913, Order No. 46115470) distributed nationwide to AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN, and WV.
The recall was initiated because severe thunderstorms caused transit delays of certain cold chain products. This delay resulted in products being stored outside the manufacturer's recommended labeled storage conditions, which could compromise product integrity.
When test cassettes are stored outside recommended temperature conditions, the probability of an incorrect test result or a delayed test result may increase. Consumers who have received affected products should contact their healthcare provider or the recalling firm for guidance on whether their cassettes were affected.
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-condition-deviation
- incorrect-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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