FDA Medical Device Recalls (openFDA)
Perkin Elmer: Specimen Gate Lab - MSMS Data Suite, Product Code: 5002-0310. The intended use of the product is data management in prenatal and neonatal screening laboratories designed to allow viewing and management of assay results.
- Recall number
- Z-1906-2009
- Recalling firm
- Perkin Elmer
- Product
- Specimen Gate Lab - MSMS Data Suite, Product Code: 5002-0310. The intended use of the product is data management in prenatal and neonatal screening laboratories designed to allow viewing and management of assay results.
- Status
- Terminated
- Initiated
- 2009-01-15
- Posted
- 2009-08-25
- Terminated
- 2011-09-09
- Reason
- If Result Codes are used and if they are manually edited, they are correct unless the laboratory specifically uses the View Assay button in the Specimen History screen to open another assay, and then returns back to the original assay
- Root cause
- Software design
- Action
- Perkin Elmer began notifying US customers January 15, 2009. Notification included instructions for how to avoid the situation and instructions for how to obtain a correction. The firm requested consignees to send in a Response Form by fax (358-2-2678-357) or by email (TurkuQMresponse@perkinelmer.com). For further information, please contact your closest Specimen Gate support center at specimen.gate.support@perkinelmer.com for North America and specimengatesupportfi@perkinelmer.com for outside of North America.
- Quantity
- 13 units
- Distribution
- Worldwide Distribution -- United States (AL, AZ, CA, CO, CT, FL, GA, IN, KS, KY, MI, MO, OH, OK, OR, TN and TX) and Canada.
- Lot, serial or model codes
- Software versions: 1.2 and 1.3.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 3006159931
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
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