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.
- Recall Initiated
- January 10, 2019
- Recall Number
- Z-1237-2019
- Quantity
- 31 kits (10 in US, 21 in ROW)
- Firm Location
- Turku Finland
Reason for Recall
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Distribution
Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.
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
Root Cause
Nonconforming Material/Component
Action Taken
Perkin Elmer initiated notification on January 10, 2018. The Recall Letter delivered to the end customer by email facilitated through the PerkinElmer Technical Support Group. PerkinElmer requires customers to: Inspect DELFIA / AutoDELFIA hCG kit inventory for the affected lots. Review your QC follow-up of the AutoDELFIA hCG assay for potential decrease in the control concentrations. If the control values are within your established acceptance range it is safe to report the results To avoid unnecessary repeat testing of samples, if the control values are out of the acceptance range discontinue use of the DELFIA / AutoDELFIA hCG kit lot and dispose the remaining kits of the lot. Complete the Response Form with the quantity of affected DELFIA / AutoDELFIA hCG kits you have disposed from your inventory