FDA Medical Device Recalls (openFDA)
Dade Behring , Inc.: Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit.
- Recall number
- Z-1305-04
- Recalling firm
- Dade Behring , Inc.
- Product
- Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit.
- Status
- Terminated
- Initiated
- 2004-06-07
- Posted
- 2004-07-31
- Terminated
- 2005-01-06
- Reason
- Customers have reported a high rate of instrument error flags and calibration issues when using affected reagent.
- Root cause
- Other
- Action
- The recalling firm sent a recalling letter to the direct accounts informing them that the affected lots can not be used for heparin determinations. Direct account were instructed
- Quantity
- 781 kits
- Distribution
- The heparin reagent, which is a component of a test kit, wasdistributed to direct accounts in the following states: AZ, CA, CO, FL, IA, IL, IN, KY, OH, MA, MD, MI, MN, NC, NE, NJ, NM, NY, PA,TN, TX, WI, WV. Further, there are foreign countries also affected in this recall action, as listed: Australia, Canada, France, Finland, Germany, Israel, Italy, Spain, United kingdom, Spain
- Lot, serial or model codes
- Lots 541428, 541429, expiration date of Nov 2006
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KFF
- 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