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Terminated

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.

FDA Recall Z-1905-2009 · Posted 2009-08-25

Recalling FirmPerkin Elmer
Recall StatusTerminated
Product CodeJQP
Date Initiated2009-01-15
Date Terminated2011-09-09
Product Quantity26 units

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

Firm 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.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution -- United States (AL, AZ, CA, CO, CT, FL, GA, IN, KS, KY, MI, MO, OH, OK, OR, TN and TX) and Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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