Z-0779-2017Class III

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

Name: Z-0779-2017 DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
Creator: PerkinElmer Health Sciences, Inc.
Published: 2016-11-16
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2016-11-16 / Terminated

FDA source

PerkinElmer Health Sciences, Inc. began a recall of DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum on 2016-11-16. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0779-2017
Classification: Class III
Status: Terminated
Initiated: 2016-11-16
Posted: 2016-12-16
Terminated: 2017-07-05
Recalling firm: Revvity Health Sciences, Inc.
Product: DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
Product code: CGJ Radioimmunoassay, Follicle-Stimulating Hormone
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.
FDA root cause: Other
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.
Quantity in commerce: 79 kits
Distribution: CA, CO, NY, WA Foreign: Austria, Bolivia, Bosnia , Sweden, Norway, Netherlands, Japan, Great Britain,
Product codes and lots: Lot Number: 646091

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0779-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0779-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-16

Product code CGJ

K862043Class IDelfia (Tm) Hfsh KitLkb Instruments, Inc. / cleared 1986-06-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)