FDA Medical Device Recalls (openFDA)
Dade Behring , Inc.: StreamLab Analytical Workcell. General Purpose Laboratory Device.
- Recall number
- Z-0373-05
- Recalling firm
- Dade Behring , Inc.
- Product
- StreamLab Analytical Workcell. General Purpose Laboratory Device.
- Status
- Terminated
- Initiated
- 2004-11-12
- Posted
- 2004-12-28
- Terminated
- 2005-03-28
- Reason
- Software can sample the incorrect specimen from the StreamLAB to the Dimension RxL or RxL Max Systems.
- Root cause
- Other
- Action
- The recalling firm issued letters dated 11/12/04 to their customers informing them of the problem. The letter also states that a sales representative will contact them to make arrangements for an upgrade.
- Quantity
- 15 units
- Distribution
- The product was shipped to hospitals in IL, MD, NJ, OH, and VA. The product was also shipped to Italy, Spain, and Portugal.
- Lot, serial or model codes
- Software version 3.5
- 510(k) numbers
- not on file
- 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