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DATE NOTIFICATION INITIATED: May 13, 2004 PRODUCT: Ortho Assay Software; Version 2.0 MANUFACTURER: Ortho Clinical Diagnostics, Inc. Raritan, New Jersey REASON: Ortho Clinical Diagnostics (OCD) has received reports that sample or reagent could be dispensed twice if an ‘Error 137’ is generated during the pipetting of a plate. If the error is generated while fluid is being dispensed to a microplate, the instrument activity stops and the user is required to respond to the message. If the user chooses to “Continue” and the instrument is in the dispensing step, the dispense step may inadvertently be repeated. If an ‘Error 137’ occurs during pipetting, consignees are asked to follow the instructions described in OCD’s “Important Information Notification” dated May 13, 2004. 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 September 30, 2004

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