FDAJanuary 10, 2019device

AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).

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

The hazard

hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.

What to do

FDA enforcement status: Ongoing

Brands named

perkinelmer life and analytical sciences wallac oyperkinelmerperkinelmer life

UPCs

06438147009343

Recall history

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

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