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).
Check against the official notice below — it lists the full affected range.
PerkinElmer Life and Analytical Sciences is recalling the AutoDELFIA hCG Kit (Product Code: B007-112), which is used to measure human gonadotropin (hCG) levels. The kits affected are those with Lot Number 664303 and Pack Lot Numbers 1066430301 or 1066430302. The problem identified is that hCG analyte concentrations may be decreased by up to 15-20% in the lower measuring range of hCG concentrations. A total of 304 kits were distributed in the United States, with additional distribution to Austria, Bolivia, the UK, Switzerland, Thailand, and Finland.
The recall notice does not specify a remedy or what affected consumers should do with the recalled kits.
Written by software from the official notice below. Not reviewed by a lawyer.
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
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. Quantity: 304 kits (United States) Lot/code info: Kit Lot Numbers: 664303 Pack Lot Numbers: 1066430301, 1066430302 UDI: (01)06438147009343(17)190430(10)664303
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.