PerkinElmer Health Sciences, Inc. recalls DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum

Recall date

November 16, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0779-2017

FDA classification

Class III

Brand / firm

PerkinElmer Health Sciences, Inc.

Sold / distributed

CA, CO, NY, WA Foreign: Austria, Bolivia, Bosnia , Sweden, Norway, Netherlands, Japan, Great Britain,

Why it was 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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum