Z-1116-2012

Perkin Elmer Genetic Screening Processor (GSP)

Name: Z-1116-2012 Perkin Elmer Genetic Screening Processor (GSP)
Creator: PerkinElmer Life and Analytical Sciences, Wallac, OY
Published: 2012-01-09
License: https://open.fda.gov/license/

Wallac Oy / initiated 2012-01-09 / Terminated / root cause: manufacturing process

FDA source

PerkinElmer Life and Analytical Sciences, Wallac, OY began a recall of Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in... on 2012-01-09. The reason FDA records is "GSP instruments with defective washer modules may cause a false negative screening result being reported for T4, TSH and IRT. For 17-OHP, a false positive result may be generated if the failure occurs for a normal sample". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1116-2012
Status: Terminated
Initiated: 2012-01-09
Posted: 2012-02-28
Terminated: 2013-03-06
Recalling firm: Wallac Oy
Product: Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids.
Product code: KHO Fluorometer, For Clinical Use
Reason for recall: GSP instruments with defective washer modules may cause a false negative screening result being reported for T4, TSH and IRT. For 17-OHP, a false positive result may be generated if the failure occurs for a normal sample.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Perkin Elmer issued an "Urgent Medical Device Recall" letter dated 1/25/12 to all customers and informed them about the possible issue and requested permission for service personnel to check their instrument. The customers were instructed that the instrument could not be used and the washer module required replacement. Customers were told to expect to be contacted by the firm's local representative for further details.
Quantity in commerce: 10 units
Distribution: Worldwide Distribution - USA, including the states of Florida, Ohio, Oregon, Texas and the countries of Brazil, Belgium, France, Germany, and the UK.
Product codes and lots: Serial numbers from 20210012 to 20210021

Product code KHO

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