Recall Z-1376-06 ยท GKL Counter, Cell, Automated (Particle Counter)
Bayer Healthcare, LLC (Diagnostics Division)
ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter
| Date | Aug 4, 2006 (initiated Mar 16, 2006) |
| Status | Terminated |
| Reason | The ADVIA 2120 has reported ; highly intermittent low results on all primary results: White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HGB) and Platelets (PLT) and an abnormal baso cytogram. |
| Root cause | Other |
| Action | Bayer HealthCare LLC issued Support Bulletins to all affected Bayer HealthCare LLC Branches on 3/16/06 in order to inform them of the issue and to provide them with instructions for this ''field correction''. Bayer also issued Customer Bulletins to the Branches both in the United States and elsewhere for communication with the affected customers. |
| Quantity | 60 units Domestic, 258 units Foreign |
| Distribution | Worldwide distribution-Domestic consignees consist of hospitals and clinical laboratories. Foreign countries (units): Canada (1), China (4), Singapore (1), Malaysia (2), Thailand (1), Taiwan (1), Vietnam (1), Australia (3), Korea (25), Japan (25), Israel (4), Saudi Arabia (4), Russia (1), Turkey (1) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971998 | ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM Bayer Corp., Aug 29, 1997 |