Recall Z-1108-2008

Reason for recall

Erroneous Results - UniCel Dxl Access Immunoassay Systems Reaction Vessels have been found to be defective and there is a potential for an increase in signal leading to an erroneous result.

FDA-determined cause: Process design

Action taken

A Product Corrective Action (PCA) letter was mailed on July 19, 2007, to the Customers that received UniCel Dxl Access lmmunoassay System Reaction Vessels lot 1201291 and 1201431. The customers were informed that a small percentage of the reaction vessels (Lot #s: 1201291and 1201431 ) have been found to be defective and there is a potential for an increase in signal leading to an erroneous result. The customers were instructed to discontinue use and discard these lots. A response form was included.