Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0779-2017 — DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum

U.S. FDA — Device Enforcement · United States · 2016-11-16 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0779-2017
Date of alert
2016-11-16
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
PerkinElmer Health Sciences, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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