Home / Recalls / Helena Laboratories, Inc. / Z-0594-2019

Z-0594-2019 Class II Terminated

Recalled by Helena Laboratories, Inc. — Beaumont, TX

Recall Details

Product Type
Devices
Report Date
December 19, 2018
Initiation Date
April 20, 2016
Termination Date
February 15, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12 Kits

Product Description

Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.

Reason for Recall

Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected

Distribution Pattern

US Distribution to state of TX and internationally to: Australia, Netherlands, Italy, and England.

Code Information

Lot Codes: 1-15-5701 Model/Catalog Number: 5701

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