Z-0779-2017 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 28, 2016
- Initiation Date
- November 16, 2016
- Termination Date
- July 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 79 kits
Product Description
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
Reason for Recall
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.
Distribution Pattern
CA, CO, NY, WA Foreign: Austria, Bolivia, Bosnia , Sweden, Norway, Netherlands, Japan, Great Britain,
Code Information
Lot Number: 646091