Recall Z-1905-2009
Perkin Elmer · initiated January 15, 2009
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.
Codes / lots: Software Versions: 1.2 and 1.3.
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
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-1905-2009
- Initiated
- January 15, 2009
- Posted by FDA
- August 25, 2009
- Terminated
- September 9, 2011
- Product code
- JQP – Calculator/Data Processing Module, For Clinical Use
- Quantity
- 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.
- Recalling firm
- Perkin Elmer, Waltham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1906-2009 | Specimen Gate Lab - MSMS Data Suite, Product Code: 5002-0310. The intended use of the…If Result Codes are used and if they are manually edited, they are correct unless the laboratory… | 01/15/2009Terminated |