CELL-DYN Sapphire Hematology Analyzer, List number 08H00-01, LIS/ Middleware Interface Specification, Abbott Diagnostics
FDA device recall Z-2139-2008 · posted 2008-08-21 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- 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.
- 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.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 15 copies of the specification were sent worldwide
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-04-11
- Date posted
- 2008-08-21
- Date terminated
- 2010-03-12
- Location
- Santa Clara, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELL-DYN SAPPHIRE SYSTEM (K051215) | Abbott Laboratories | 2005-07-21 |