Recall Z-1906-2009 ยท JQP Calculator/Data Processing Module, For Clinical Use
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.
| Date | Aug 25, 2009 (initiated Jan 15, 2009) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.