Z-1905-2009

Specimen Gate Laboratory

Name: Z-1905-2009 Specimen Gate Laboratory
Creator: Perkin Elmer
Published: 2009-01-15
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2009-01-15 / Terminated / root cause: software

FDA source

Perkin Elmer began a recall of Specimen Gate Laboratory, Product Code: 5002-0180, Software Version: 1.2 and 1.3. The intended use of the product is data management in prenatal and neonatal... on 2009-01-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1905-2009
Status: Terminated
Initiated: 2009-01-15
Posted: 2009-08-25
Terminated: 2011-09-09
Recalling firm: Revvity Health Sciences, Inc.
Product: Specimen Gate Laboratory, Product Code: 5002-0180, Software Version: 1.2 and 1.3. The intended use of the product is data management in prenatal and neonatal screening laboratories designed to allow viewing and management of assay results.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: 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 tag: software
FDA 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 ([email protected]). For further information, please contact your closest Specimen Gate support center at [email protected] for North America and [email protected] for outside of North America.
Quantity in commerce: 26 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.
Product codes and lots: Software Versions: 1.2 and 1.3.

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)