medical Class II Updated 2018-12-12

Helena Laboratories, Inc. recalls Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOST

Recalled Product

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


Hazard / Issue

Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.

Issued by

FDA

Affected States: TX
Lot/Code Info: Lot Codes: 1-16-5701 Model/Catalog Number: 5701
View official government recall

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