FDA Medical Device Recalls (openFDA)
Dade Behring , Inc.: DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
- Recall number
- Z-0042-05
- Recalling firm
- Dade Behring , Inc.
- Product
- DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
- Status
- Terminated
- Initiated
- 2004-08-27
- Posted
- 2004-10-23
- Terminated
- 2005-05-10
- Reason
- APTT determinations when using affected rotors may lead to incorrectly shortened times
- Root cause
- Other
- Action
- 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.
- Quantity
- 7140 units
- Distribution
- The product was shipped to medical facilities nationwide. The product was shipped to one government facility in TN.
- Lot, serial or model codes
- Lot numbers 57295, 57304, 57400, 57463, 57504, 57562, 57579, 57601, 57674, 57685, 57755, 57819, 57820, and 57832
- 510(k) numbers
- ["K011665"]
- PMA numbers
- not on file
- Product code
- JPA
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28