Z-2121-2012Class II

Perkin Elmer Genetic Screening Processor (GSP)

Name: Z-2121-2012 Perkin Elmer Genetic Screening Processor (GSP)
Creator: Perkinelmer
Published: 2012-06-27
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2012-06-27 / Terminated / root cause: design

FDA source

Perkinelmer began a recall of Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer... on 2012-06-27. FDA classified it as Class II and gives the reason as "Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for Genetic Screening for Neonatal IRT, TSH and IRT". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2121-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-27
Posted: 2012-08-01
Terminated: 2014-04-18
Recalling firm: Revvity Health Sciences, Inc.
Product: Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument.
Product code: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Reason for recall: Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for Genetic Screening for Neonatal IRT, TSH and IRT
Root cause tag: design
FDA root cause: Component design/selection
Action: PerkinElmer sent an Urgent: Medical Device Recall letter dated June 27, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that replacement units of the recalled product will be installed as soon as they are available. Customers were instructed to complete and return the response form attached. For further information contact your local PerkinElmer representative or GS. [email protected]
Quantity in commerce: 78 units
Distribution: Worldwide Distribution - US (nationwide) and the countries of Australia, Belgium, Brazil, Egypt, France, Germany, Netherlands, Norway, Saudi Arabia,Switzerland,
Product codes and lots: Serial Numbers: 20210001 through 20210078

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2121-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2121-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-07-31

Product code JLW

K090846Class IIGsp Instrument and Gsp Neonatal Htsh KitPerkinelmer, Inc. / cleared 2009-09-03

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)