Bayer Advia 70 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.
FDA device recall Z-0448-2007 · posted 2007-01-09 · Terminated
Recall details
- Recalling firm
- Drew Scientific Group PLC
- Reason for recall
- Flags and alerts on the user interface will not automatically transfering to the LIS.
- Action taken
- Firm sent 'Product Notification #22' to all customers on 08/24/06. Users advised of potential risk to patient health and provided with instructions on how to eliminate risk by disabling the auto transfer feature and manually transfering data until a software patch is made available
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 545 units.
- Distribution
- Worldwide distribution --- including USA states of FL, MA, MN, ND, NM, NY, Puerto Rico and TX and countries of Austria, Bangladesh, Chile, China, Czech Republic, Egypt, France, Hong Kong, Italy, India
- Date initiated
- 2006-08-24
- Date posted
- 2007-01-09
- Date terminated
- 2008-03-10
- Location
- Dallas, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXCELL 22 (K991539) | Mwi, Inc. | 1999-07-01 |