DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
FDA device recall Z-0042-05 · posted 2004-10-23 · Terminated
Recall details
- Recalling firm
- Dade Behring , Inc.
- Reason for recall
- APTT determinations when using affected rotors may lead to incorrectly shortened times
- Action taken
- The recalling firm issued a recall letter dated 8/27/04 to their direct accounts informing them of the problem. The recalling firm also sent instructions for a work around until a solution can be established.
- Root cause
- Other
- Status
- Terminated
- Product code
- JPA
- Quantity affected
- 7140 units
- Distribution
- The product was shipped to medical facilities nationwide. The product was shipped to one government facility in TN.
- Date initiated
- 2004-08-27
- Date posted
- 2004-10-23
- Date terminated
- 2005-05-10
- Location
- Newark, DE
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BCT SYSTEM (K011665) | Dade Behring, Inc. | 2001-08-09 |