ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter
FDA device recall Z-1376-06 · posted 2006-08-04 · Terminated
Recall details
- Recalling firm
- Bayer Healthcare, LLC (Diagnostics Division)
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKL
- Quantity affected
- 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), Viet
- Date initiated
- 2006-03-16
- Date posted
- 2006-08-04
- Date terminated
- 2012-05-24
- Location
- Tarrytown, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM (K971998) | Bayer Corp. | 1997-08-29 |