Perkinelmer: Medical Device Recall in 2012 - (Recall #: Z-2121-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 27, 2012

Date Posted: August 8, 2012

Recall Number: Z-2121-2012

Event ID: 62512

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

Status: Terminated

Product Quantity: 78 units

Code Information:

Serial Numbers: 20210001 through 20210078

Distribution Pattern:

Worldwide Distribution - US (nationwide) and the countries of Australia, Belgium, Brazil, Egypt, France, Germany, Netherlands, Norway, Saudi Arabia,Switzerland,

Voluntary or Mandated:

Voluntary: Firm initiated