FDA Medical Device Recalls (openFDA)
Dade Behring , Inc.: Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.
- Recall number
- Z-0538-05
- Recalling firm
- Dade Behring , Inc.
- Product
- Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.
- Status
- Terminated
- Initiated
- 2004-12-03
- Posted
- 2005-02-15
- Terminated
- 2005-10-18
- Reason
- decrease in product stability after reconstitution and reduced stability on board certain instrument systems
- Root cause
- Other
- Action
- The recalling firm issued a recall letter to their customers informing them of the problem and the need to use internal quality controls with the analyzers. The letter instructed customer to discard lot # 544545 and reduce the stability for the other lot numbers involved.
- Quantity
- 25381 units
- Distribution
- The product was shipped nationwide to medical facilities.
- Lot, serial or model codes
- Lot numbers 544531 to 544548 and 544502 to 544504.
- 510(k) numbers
- ["K041438"]
- PMA numbers
- not on file
- Product code
- DAP
- 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