Perkin Elmer 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Perkin Elmer
Lot Codes / Batch Numbers
Software Versions: 1.2 and 1.3.
Products Sold
Software Versions: 1.2 and 1.3.
Perkin Elmer is recalling Specimen Gate Laboratory, Product Code: 5002-0180, Software Version: 1.2 and 1.3. The intended use due to 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 Specim. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026