FDA Device recall Z-0779-2017
DELFIA hFSH kit
- FDA Device
- Class III
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class III recall of DELFIA hFSH kit by Perkinelmer Health Sciences, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0779-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-11-16 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Perkinelmer Health Sciences |
| Distribution | CA, CO, NY, WA |
Product
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
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.
Identifiers
| code_info | Lot Number: 646091 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0779-2017%22
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