AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - 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 AutoDELFIA hCG Kit (Product Code: B007-101), which is used to measure human gonadotropin levels. The affected kits have lot numbers 664670 and 666553, with a total of 79 kits recalled worldwide, though none were distributed in the United States. The kits were distributed to Austria, Bolivia, the UK, Switzerland, Thailand, and Finland.
The kits may show decreased hCG analyte concentrations of up to 15-20% at the lower measuring range, which could affect the accuracy of test results at lower hCG levels. The source does not specify what consumers or healthcare providers should do 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: 79 kits (none in US, all in ROW) Lot/code info: Kit Lot Numbers: 664670, 666553 Pack Lot Numbers: 1066467001, 1066467002, 1066655301 UDI: (01)06438147009336(17)190430(10)664670 (01)06438147009336(17)190430(10)666553
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.