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Recall Observatory FDA recall evidence

Device product

K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.

Z-0635-2021

November 09, 2020

Class II

Product summary

Firm
Helena Laboratories, Corp.
Event
Event 86774
Status
Ongoing
Classification
Class II
Quantity
Lot 1-19-K-ACT = 314 tubes and Lot 2-19-K-ACT = 297 tubes
Official record key
device-enforcement:Z-0635-2021

Official wording

Reason: Due to complaints received associated with cracked/split test tube caps.

Code information: Catalog Number: K-ACT Lot Number: 1-19-K-ACT and 2-19-K-ACT

Distribution pattern: Worldwide distribution - U.S. Nationwide including in the states of NJ, NY, PA and TX. The countries of Austria, Canada, England, France, Italy, Portugal, Russia, Spain.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to complaints received associated with cracked/split test tube caps.