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FDAJuly 21, 2017device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

helena laboratorieshelena

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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