Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.
FDA device recall Z-0451-2007 · posted 2007-01-05 · Terminated
Recall details
- Recalling firm
- Drew Scientific Group PLC
- Reason for recall
- System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platlet counts.
- Action taken
- Firm sent 'Technical Bulletin #39' to all customers on 09/20/06. Users advised of potential for inaccurate readings and provided with instructions on how to eliminate problem.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 299 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, Indi
- Date initiated
- 2006-09-20
- Date posted
- 2007-01-05
- 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 |