Recall Z-2139-2008 ยท GKZ Counter, Differential Cell
Abbott Laboratories
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.
| Date | Aug 21, 2008 (initiated Apr 11, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software change control |
| Action | 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 |
| Quantity | 15 copies of the specification were sent worldwide |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051215 | CELL-DYN SAPPHIRE SYSTEM Abbott Laboratories, Jul 21, 2005 |