Z-0603-2012

The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put batch...

Name: Z-0603-2012 The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put batch...
Creator: PerkinElmer LAS, Inc
Published: 2011-10-24
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2011-10-24 / Terminated / root cause: design

FDA source

PerkinElmer LAS, Inc began a recall of The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put batch analyzer for time- resolved and prompt fluorescence... on 2011-10-24. The reason FDA records is "Malfunction of the GSP disk remover unit may cause a punched disc to remain in the well during the measurement of the plate. This may cause a false negative screening result being reported for 17-OHP, resulting in...". 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-0603-2012
Status: Terminated
Initiated: 2011-10-24
Posted: 2012-01-11
Terminated: 2012-07-20
Recalling firm: Revvity Health Sciences, Inc.
Product: The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put 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 chemistries running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders.
Product code: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Reason for recall: Malfunction of the GSP disk remover unit may cause a punched disc to remain in the well during the measurement of the plate. This may cause a false negative screening result being reported for 17-OHP, resulting in failure to identify cases of congenital adrenal hyperplasia (CAH).
Root cause tag: design
FDA root cause: Device Design
Action: Recall (correction) letters were sent to all customers on October 24, 2011. An improved disk remover design is under development to eliminate the reported problem. Until the final field correction is available, customers should follow the precautions provided. The needed protocol update will be performed by the local service engineer. If customers observe an increase in the occurrence of the problem, the laboratory should contact their local PerkinElmer representative.
Quantity in commerce: 52
Distribution: Worldwide Distribution - USA, including the states of: Missouri, Florida, Texas, Oregon, Alabama, Louisiana, New Jersey, Georgia, Virginia, Kentucky and the countries of: Australia, Belgium, Brazil, Egypt, France, Germany, Italy, Netherlands, Norway, Qatar, Saudi MOH, Switzerland, and the UK.
Product codes and lots: Product Code 2021-0010

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)