Device product
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).
Z-1239-2019
Product summary
- Event
- Event 82064
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 304 kits (United States)
- Official record key
device-enforcement:Z-1239-2019
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: 664303 Pack Lot Numbers: 1066430301, 1066430302 UDI: (01)06438147009343(17)190430(10)664303
Distribution pattern: Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.
Derived failure modes
-
Unknown
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.