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Helena Laboratories, Corp. recalls SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laborato
Recalled October 16, 2019 · FDA recall Z-0045-2020 · Helena Laboratories
Hazard
The plates do not have wells punched for the controls in the patient 1 area. · FDA Class II
Units
24 kits
Sold at
Distribution was made to IN, KY, MA, OH, OR, TN, and TX. There was government distribution. Foreign distribution was made to Chile.
Description
The plates do not have wells punched for the controls in the patient 1 area.
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.
Manufacturer(s)
Helena Laboratories, Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →