Reported May 8, 2019 · Ongoing
AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 -…
PerkinElmer Life and Analytical Sciences, Wallac, OY
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PerkinElmer Life and Analytical Sciences, Wallac, OY · Mustionkatu 6 · Turku, N/A · N/A
Is this the product you have?
- AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of
- human gonadotropin (hCG) Product CodeB007-101 -
- Product UsageQuantitative determination of human gonadotrophin (hCG)
- Lot codes and dates
- Kit Lot Numbers
664670666553
- Pack Lot Numbers
106646700110664670021066655301
- UDI(01)06438147009336(17)190430(10)664670 (01)06438147009336(17)190430(10)666553
- Kit Lot Numbers
- Amount recalled
- 79 kits (none in US, all in ROW)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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