Specimen Gate Lab - MSMS Data Suite, Product Code: 5002-0310. The intended use of the product is data management in pren

FDA device recall Z-1906-2009 · posted 2009-08-25 · Terminated

Recall details

Recalling firm

Perkin Elmer

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

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.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

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.

Date initiated

2009-01-15

Date posted

2009-08-25

Date terminated

2011-09-09

Location

Waltham, MA