FDA-Device2016-12-28Class III
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
PerkinElmer Health Sciences, Inc.
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.
Sold states
CA, CO, NY, WA Foreign: Austria, Bolivia, Bosnia , Sweden, Norway, Netherlands, Japan, Great Britain,
Affected count
79 kits
Manufactured in
940 Winter St, N/A, Waltham, MA, United States
Products
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0779-2017Don't want to check this manually?
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