Device 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.

Z-1237-2019

January 10, 2019

Class II

Product summary

Firm: PerkinElmer Life and Analytical Sciences, Wallac, OY
Event: Event 82064
Status: Ongoing
Classification: Class II
Quantity: 31 kits (10 in US, 21 in ROW)
Official record key: device-enforcement:Z-1237-2019

Official wording

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

Code information: 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

Distribution pattern: Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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