FDA Medical Device Recalls (openFDA)
Dade Behring , Inc.: Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100
- Recall number
- Z-0304-06
- Recalling firm
- Dade Behring , Inc.
- Product
- Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100
- Status
- Terminated
- Initiated
- 2005-09-23
- Posted
- 2005-12-23
- Terminated
- 2006-05-11
- Reason
- prolonged aPTT results
- Root cause
- Other
- Action
- The recalling firm issued a letter dated 9/30/05 informing the customers of the problem and instructing them to discontinue use of the product.
- Quantity
- 4176 packs
- Distribution
- The products were shipped to medical facilities and/or laboratories nationwide.
- Lot, serial or model codes
- Lot number 527263 exp 2/3/06
- 510(k) numbers
- ["K811589"]
- PMA numbers
- not on file
- Product code
- GGW
- 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