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PerkinElmer Health Sciences, Inc. recalls DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
Recalled December 28, 2016 · FDA recall Z-0779-2017 · PerkinElmer Health Sciences
Hazard
A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrated a decrease in hFSH concentrations between -4.8% to -11.3% for control sera. The -11.3% bias was observed at an hFSH target concentration of 101 IU/L. The change observed in the serum samples within the range 1.76 67.0 IU/L hFSH averaged -2.9%. The reference range of the assay spans 0.60 to 98.0 IU/L. · FDA Class III
Units
79 kits
Sold at
CA, CO, NY, WA Foreign: Austria, Bolivia, Bosnia , Sweden, Norway, Netherlands, Japan, Great Britain,
Description
A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrated a decrease in hFSH concentrations between -4.8% to -11.3% for control sera. The -11.3% bias was observed at an hFSH target concentration of 101 IU/L. The change observed in the serum samples within the range 1.76 67.0 IU/L hFSH averaged -2.9%. The reference range of the assay spans 0.60 to 98.0 IU/L.
Product
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
Manufacturer(s)
PerkinElmer Health Sciences, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →