Abbott Laboratories Recalls
Showing 101-120 of 153 recalls
Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; List Number: 09H39-01; Field Replaceable Unit (FRU) Numbers: 8701686901, 8701686902; Product is distributed by Abbott Diagnostics Division, Santa Clara. CA and manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, IL Intended use: The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.
There is the potential for the instrument to not power up due to the flash memory issue. This will result in an error message displayed is "No Memory Available" and has the potential for delay in generating patient results.
The firm, Abbott Laboratories, sent a "Product Correction" letter dated October 15, 2010 to all customers. The letter described the product, problem and action to be taken by the customer. The customers were instructed to install a new printer driver in the software location using the provided instructions and to complete and return the Customer Reply Form via fax 1-800-777-0051 or email to QAGCO@abbott.com even if they no longer have the instrument. If you have any questions regarding this information, U.S. customers should call Customer Support at 1-877-4ABBOTT; customers outside the U.S., please contact your local hematology customer support representative.
CELL-DYN Sapphire Probe Detector PCB Assembly (also called the Aspiration Bottom Sensor) used on the Cell-Dyn Sapphire Hematology Analyzer, Manufactured by Abbott Laboratories, Santa Clara, CA
Under certain conditions in closed mode of operations, the Aspiration Probe Detector PCB assembly may fail to operate properly and provide inaccurate results.
Abbott Diagnostics Division of Santa Clara, CA initiated a field correction of the CELL-DYN Sapphire Probe Detector Assembly used on the CELL-DYN Sapphire Hemotology Analyzer, on April 5, 2010. The correction is being addressed through field service representatives and a mandatory Technical Service Bulletin (TSB). The TSB requires inspection, testing, and potential replacement of the affected assembly. The firm will not be issuing a seperate notification. For questions regarding this correction please contact (408) 982-4800, or fax (408) 982-4863.