—#70261

Product

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.

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K051215
Affected lot / code info: Revision B.

Why it was recalled

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 (FDA determination)

Software change control

Action the firm took

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.

Recalling firm

Firm: Abbott Laboratories
Address: 5440 Patrick Henry Dr, Santa Clara, California 95054-1113

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2008-04-11
Posted by FDA: 2008-08-21
Terminated: 2010-03-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70261. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.