Home / Recalls / Helena Laboratories, Corp. / Z-0635-2021

Z-0635-2021 Class II Ongoing

Recalled by Helena Laboratories, Corp. — Beaumont, TX

Recall Details

Product Type
Devices
Report Date
December 23, 2020
Initiation Date
November 9, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Lot 1-19-K-ACT = 314 tubes and Lot 2-19-K-ACT = 297 tubes

Product Description

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.

Reason for Recall

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

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.

Code Information

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

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