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Terminated

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

FDA Recall Z-0779-2017 · Posted 2016-12-16

Recalling FirmPerkinElmer Health Sciences, Inc.
Recall StatusTerminated
Product CodeCGJ
Date Initiated2016-11-16
Date Terminated2017-07-05
Product Quantity79 kits

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.

Firm Action

PerkinElmer initiated recall on November 16, 2016, delivered to the end customer by email facilitated through the PerkinElmer Technical Support group located in Akron Ohio. Technical Support will be asked to make sure the customers receive the Recall Letter and understand the recommended actions. Users asked to inspect inventory, discontinue use destroy the kits and complete the Response Forms and Destruction.Replacement kits will shipped.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K862043DELFIA (TM) HFSH KITLkb Instruments, Inc. · 1986-06-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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