medical Class II Updated 2019-05-08

PerkinElmer Life and Analytical Sciences, Wallac, OY recalls DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination o

Recalled Product

DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.


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: 664891, 666471, 666604 Pack Lot Numbers: 1066489101, 1066647101,1066660401 UDI: (01)06438147009176(17)190430(10)664891 (01)06438147009176(17)190430(10)666471 (01)06438147009176(17)190430(10)666604
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