FDA Medical Device Recalls (openFDA)
Dade Behring , Inc.: Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method.
- Recall number
- Z-0172-06
- Recalling firm
- Dade Behring , Inc.
- Product
- Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method.
- Status
- Terminated
- Initiated
- 2005-07-29
- Posted
- 2005-11-18
- Terminated
- 2006-03-01
- Reason
- Reports of false negative results on Sysmex Coagulation System.
- Root cause
- Other
- Action
- On 7/29/05, the recalling firm issued a recall letter to their accounts informing them of the probelm. The letter also provided instruction on how to prevent the probelm from occurring - change from the AKIMA method to the Point ot Point method.
- Quantity
- 2987 units
- Distribution
- The product was shipped to medical facilities nationwide.
- Lot, serial or model codes
- Catalog number OQWM
- 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