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U.S. Department of Health and Human Services

Class 2 Device Recall Perkin Elmer Specimen Gate Systems

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  Class 2 Device Recall Perkin Elmer Specimen Gate Systems see related information
Date Initiated by Firm January 15, 2009
Date Posted August 25, 2009
Recall Status1 Terminated 3 on September 09, 2011
Recall Number Z-1905-2009
Recall Event ID 51336
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
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.
Code Information Software Versions: 1.2 and 1.3.
Recalling Firm/
Manufacturer		 Perkin Elmer
940 Winter St
Waltham MA 02451-1457
Manufacturer 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 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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