CELL-DYN Sapphire Hematology Analyzer, List number 08H00-01, LIS/ Middleware Interface Specification, Abbott Diagnostics Division, Santa Clara, CA For in vitro diagnostic use in counting and characterizing blood cells.
- Company
- Abbott Laboratories
- Recall Initiated
- April 11, 2008
- Posted
- August 21, 2008
- Terminated
- March 12, 2010
- Recall Number
- Z-2139-2008
- Quantity
- 15 copies of the specification were sent worldwide
- Firm Location
- Santa Clara, CA
Reason for Recall
Table in LIS Specification depicting the association between Record ID and Numerical Result Label is incorrect. If a record ID is used to configure the system for mapping, results will come out nonsensical.
Distribution
Nationwide Distribution.
Lot / Code Info
Revision B.
Root Cause
Software change control
Action Taken
Recall initiated on April 11, 2008. A Product Correction letter and customer reply form were sent to all currently active CELL-DYN Sapphire Customers. The letter requests that users be certain that the transmission of test results receipt by the host interface is mapped according to the Numerical Result Label, when configuring their CELL-DYN Sapphire Hematology Analyzer for results transmission to a Clinical Laboratory Information System or Middleware. Affected product was distributed to a total of 4 distributors. However, notification was made to all 154 customers that received the CELL-DYNE Sapphire product. If the customer or the health care providers that they serve have any questions regarding this information, U.S. customers should call Customer Support at 1-877-4ABBOTT.