FDAClass IIAugust 8, 2012

Perkin Elmer Genetic Screening Processor recall: Contamination

Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput batch…

Why was Perkin Elmer Genetic Screening Processor recalled?

Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for Genetic Screening for Neonatal IRT, TSH and IRT

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Numbers: 20210001 through 20210078

Product
Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput batch…
Recalling firm
Perkinelmer
Quantity
78 units
Distribution
Worldwide Distribution - US (nationwide) and the countries of Australia, Belgium, Brazil, Egypt, France, Germany, Netherlands, Norway, Saudi Arabia,Switzerland,
Recall date
August 8, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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