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DATE RECALL INITIATED: November 21, 2003 LIST NUMBERS: 6A36-04,     6A36-05,     6A36-11 MANUFACTURER: Abbott Laboratories, Inc. Irving, Texas REASON: Abbott Diagnostics Division has received complaints from some ABBOTT PRISM users regarding an increase in the frequency of calibration failures and initially reactive results that were non-reactive upon retest. It has been determined that ABBOTT PRISM instruments equipped with a new model of Transfer Station (PN 1-66027-01) may exhibit splashing when the microparticle/sample mixture is transferred from the incubation well to the reaction well. Splashing at the Transfer Station may result in carryover of samples between wells leading to an increase in calibration failures, false positive test results and/or an increase in reactive rates. Abbott representatives will be contacting consignees to replace the Transfer Station on those instruments equipped with the new model of Transfer Station. The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

Updated May 17, 2004

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