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.
Check against the official notice below — it lists the full affected range.
PerkinElmer Life and Analytical Sciences is recalling the DELFIA hCG Kit (Product Code A007-101), which is used to measure human gonadotropin (hCG) levels. The kit has a defect that may cause hCG analyte concentrations to be decreased by up to 15-20% at the lower measuring range of hCG concentrations. A total of 31 kits have been distributed worldwide, including 10 kits in the United States and 21 in other countries including Austria, Bolivia, the United Kingdom, Switzerland, Thailand, and Finland.
The affected kits are identified by three lot numbers: 664891, 666471, and 666604. Affected pack lot numbers are 1066489101, 1066647101, and 1066660401. The source document does not specify what remedy or action consumers should take regarding this recall.
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: 31 kits (10 in US, 21 in ROW) 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.