FDA Medical Device Recalls (openFDA)
PerkinElmer Life and Analytical Sciences, Wallac, OY: Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids.
- Recall number
- Z-1116-2012
- Recalling firm
- PerkinElmer Life and Analytical Sciences, 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.
- Status
- Terminated
- Initiated
- 2012-01-09
- Posted
- 2012-02-28
- Terminated
- 2013-03-06
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Serial numbers from 20210012 to 20210021
- 510(k) numbers
- ["K090846"]
- PMA numbers
- not on file
- Product code
- KHO
- Firm FEI
- 3002808498
- Firm city
- Turku
- Firm state
- not on file
- Firm country
- Finland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28