Device product
ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
Z-1824-2025
Product summary
- Event
- Event 96752
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1824-2025
Official wording
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.
Code information: Catalog No. 88773; GTIN: 893038002036; Order No. 46108009.
Distribution pattern: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
Derived failure modes
-
Unknown
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.