FDAFDA · Food and drugs·Recall number Z-1239-2019
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).
Published May 8, 2019 · Recall initiated: January 10, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- PerkinElmer Life and Analytical Sciences, Wallac, OY
- Distributor
- Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.
- Lot
- Kit Lot Numbers: 664303 Pack Lot Numbers: 1066430301, 1066430302 UDI: (01)06438147009343(17)190430(10)664303
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Finland
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