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PerkinElmer Life and Analytical Sciences, Wallac, OY recalls AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Pro
Recalled May 8, 2019 · FDA recall Z-1238-2019 · 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. · FDA Class II
Units
79 kits (none in US, all in ROW)
Sold at
Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.
Description
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Product
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).
Manufacturer(s)
PerkinElmer Life and Analytical Sciences, Wallac, OY
Made in
Finland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →