Perkin Elmer Genetic Screening Processor — Class II medical device recall Z-2121-2012
Terminated recall by Perkinelmer, reported 2012-08-08, distributed nationwide. Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for Genetic Scre
| Recall number | Z-2121-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Perkinelmer, Waltham, MA, United States |
| Recall initiated | 2012-06-27 |
| Classified | 2012-07-31 |
| Reported by FDA | 2012-08-08 |
| Terminated | 2014-04-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CH, DE, EG, FR, NL, NO, SA |
| Quantity | 78 units |
| Reason classes | potency |
| Serial numbers | 20210001 |
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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2121-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.