FDA Device recall Z-1826-2025
ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST
- FDA Device
- Class II
- ongoing
- Published 2025-06-04
On 2025-06-04 the FDA classified a Class II recall of ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST by Mckesson Medical Surgical Corporate Office, citing 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 failu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1826-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-24 |
| Published | 2025-06-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Mckesson Medical Surgical Corporate Office |
| Distribution | US |
Product
ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
Reason
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.
Identifiers
| code_info | Catalog No. 97991; GTIN: 893038002937; Order No. 46102674. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1826-2025%22
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