PerkinElmer Health Sciences, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0779-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: November 16, 2016

Date Posted: December 28, 2016

Recall Number: Z-0779-2017

Event ID: 75708

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.

Status: Terminated

Product Quantity: 79 kits

Code Information:

Lot Number: 646091

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated