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[Recalled] ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES. — transit delays of certain cold chain products due to severe thunderstorms which… | FDA 2025-04-24

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
Brand / manufacturerMckesson Medical-Surgical Inc. Corporate Office
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1825-2025
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date24 April 2025
EAN / barcode893038002913

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Mckesson Medical-Surgical Inc. Corporate Office

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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