FDA-Device2019-05-08Class II
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).
PerkinElmer Life and Analytical Sciences, Wallac, OY
Hazard
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Sold states
Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.
Affected count
79 kits (none in US, all in ROW)
Manufactured in
Mustionkatu 6, P.O. Box 10, Turku, N/A, Finland
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1238-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief