Device product
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
Z-0779-2017
Product summary
- Event
- Event 75708
- Status
- Terminated
- Classification
- Class III
- Quantity
- 79 kits
- Official record key
device-enforcement:Z-0779-2017
Official wording
Reason: 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.
Code information: Lot Number: 646091
Distribution pattern: CA, CO, NY, WA Foreign: Austria, Bolivia, Bosnia , Sweden, Norway, Netherlands, Japan, Great Britain,
Derived failure modes
-
Unknown
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.