medical Class II Updated 2019-10-16

Helena Laboratories, Corp. recalls SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Di

Recalled Product

SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.


Hazard / Issue

The plates do not have wells punched for the controls in the patient 1 area.

Issued by

FDA

Affected States: IN, KY, MA, OH, OR, TN, TX
Lot/Code Info: Lot 35-17-552583, exp. date 4/30/2018
View official government recall

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