DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
Reported: December 28, 2016 Initiated: November 16, 2016 #Z-0779-2017
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.
Details
- Recalling Firm
- PerkinElmer Health Sciences, Inc.
- Units Affected
- 79 kits
- Distribution
- CA, CO, NY, WA Foreign: Austria, Bolivia, Bosnia , Sweden, Norway, Netherlands, Japan, Great Britain,
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum. Recalled by PerkinElmer Health Sciences, Inc.. Units affected: 79 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 28, 2016. Severity: Low. Recall number: Z-0779-2017.
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