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
- Affected units
- 100
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
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.
See all 32 products in this recall →Related recalls
Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office
See all →- ModerateStrep A test kits recalled after shipment to unlicensed purchasing customers
FDA (Devices) · 2025-08-27
- ModerateProlia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateEvenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateBenlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateAbbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue
FDA (Devices) · 2025-06-04
Same hazard · storage condition deviation
See all →- HighAlbuterol Sulfate Inhaler Recalled Due to Temperature Storage Deviation
FDA (Drugs) · 2024-01-03
- ModerateTerconazole Vaginal Suppositories Recalled for Temperature Storage Deviation
FDA (Drugs) · 2024-01-03