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Recall Observatory FDA recall evidence

Device product

Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.

Z-1108-2021

January 05, 2021

Class II

Product summary

Firm
Helena Laboratories, Corp.
Event
Event 87151
Status
Terminated
Classification
Class II
Quantity
205 total kits
Official record key
device-enforcement:Z-1108-2021

Official wording

Reason: Intermittent potential for shorter than expected clot times.

Code information: Model Number: 5722 Lot Numbers: 1-20-5722 expiration date 90/30/2021; 3-20-5722 expiration date 11/30/2021; 4-20-5722 expiration date 12/31/2021

Distribution pattern: Worldwide distribution - U.S. Nationwide distribution and the countries of Germany, Italy, Romania, Australia, Chile.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Intermittent potential for shorter than expected clot times.