FDA Medical Device Recalls (openFDA)
Dade Behring , Inc.: Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E
- Recall number
- Z-1040-05
- Recalling firm
- Dade Behring , Inc.
- Product
- Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E
- Status
- Terminated
- Initiated
- 2005-06-21
- Posted
- 2005-07-22
- Terminated
- 2006-05-01
- Reason
- positive control shows weak agglutination reaction
- Root cause
- Other
- Action
- The recalling firm notified their customers on 6/21/05 via letter dated 6/17/05. The customers were instructed to discontinue the use of the affected lot and discard any remaining inventory.
- Quantity
- 364 kits
- Distribution
- The product was shipped to hospital laboratories nationwide. The product was also shipped to Hungary, Switzerland, Poland, Spain, Italy, Argentina, Columbia, Mexico, Panama, Phillipines, El Salvadore, and Taiwan.
- Lot, serial or model codes
- Lot number P152010 exp 4/30/06.
- 510(k) numbers
- ["K872360"]
- PMA numbers
- not on file
- Product code
- GHH
- 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