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Recall Observatory FDA recall evidence

Device product

HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.

Z-1839-2025

April 24, 2025

Class II

Product summary

Firm
Mckesson Medical-Surgical Inc. Corporate Office
Event
Event 96752
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-1839-2025

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. 171003002; GTIN: 8718734960348; Order No. 46085136.

Distribution pattern: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.