Company:Perkin Elmer.
Date of Enforcement Report 9/30/2009
Class:ll
PRODUCT
a) 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. Recall # Z-1905-2009;
b) 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. Recall # Z-1906-2009
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.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Perkin Elmer, Waltham MA, by fax on January 15, 2009.
Manufacturer: PerkinElmer Life and Analytical Sciences, Wallac, OY, Turku, Finland. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
39units
DISTRIBUTION
Nationwide and Canada
