FDA Medical Device Recalls (openFDA)
Dade Behring, Inc.: EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE.
- Recall number
- Z-1174-2007
- Recalling firm
- Dade Behring, Inc.
- Product
- EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE.
- Status
- Terminated
- Initiated
- 2007-07-03
- Posted
- 2007-08-22
- Terminated
- 2007-11-07
- Reason
- Sample ID and Patient results could be associated with the wrong patient
- Root cause
- Other
- Action
- The recalling firm issued a Field Corrective Action letter dated 7/3/07 to inform their customers of the problem and that a software patch would be sent for them to download. The recalling firm plans to telephone the customers after the patch has been released to verify that it has been installed.
- Quantity
- 72 units
- Distribution
- Worldwide: USA including states of AZ, CA, FL, IL, MA. MI, MO, NC, OH, PA, TX, and WV. The product was also shipped to other Dade facilities in MO, DE, IL, CT, and Belgium.
- Lot, serial or model codes
- Part number 1000034941
- 510(k) numbers
- ["K051087"]
- PMA numbers
- not on file
- Product code
- JJE
- 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