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.
This recall has been terminated (originally issued August 25, 2009).
- Company
- Perkin Elmer
- Recall Initiated
- January 15, 2009
- Posted
- August 25, 2009
- Terminated
- September 9, 2011
- Recall Number
- Z-1906-2009
- Quantity
- 13 units
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
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
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 / Code Info
Software versions: 1.2 and 1.3.
Root 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.