Perkin Elmer Genetic Screening Processor Recalled for Shaker Unit Contamination
Perkinelmer is recalling 78 Genetic Screening Processor units worldwide because shaker unit contamination causes decreased signal activity in neonatal screening assays.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves decreased signal activity in neonatal screening assays, which poses a risk of harm (missed diagnoses) but does not explicitly report hospitalizations or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Perkinelmer is recalling 78 units of the Genetic Screening Processor (GSP) instrument, product code 2021-0010. The affected serial numbers range from 20210001 through 20210078. These units were distributed worldwide, including in the United States, Australia, Belgium, Brazil, Egypt, France, Germany, the Netherlands, Norway, Saudi Arabia, and Switzerland.
The recall is due to contamination from the GSP Shaker unit, which results in decreased signal activity of assay measurements. This issue affects genetic screening tests for neonatal IRT, TSH, and IRT. The GSP instrument is a fully automated, high-throughput batch analyzer intended for in vitro quantitative and qualitative determination of analytes in body fluids, specifically used to screen newborns for congenital disorders.
Healthcare facilities and laboratories using these instruments should stop using the affected units and contact Perkinelmer for further instructions. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- 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…
- Manufacturer
- Perkinelmer
- Affected units
- 78
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers: 20210001 through 20210078
Distribution
Distributed nationwide across the United States.
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