medical Class II Updated 2019-05-08

PerkinElmer Life and Analytical Sciences, Wallac, OY recalls AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determinati

Recalled Product

AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Kit Lot Numbers: 664670, 666553 Pack Lot Numbers: 1066467001, 1066467002, 1066655301 UDI: (01)06438147009336(17)190430(10)664670 (01)06438147009336(17)190430(10)666553
View official government recall

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