FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Dimension Vista System StreamLAB Analytical Workcell. Dimension Vista System Part Numbers 1000035896, 1000035899, 1000036563, and 1000036567. StreamLAB Analytical Workcell Part Number 746002.901, for in vitro diagnostic use.
- Recall number
- Z-1205-2010
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Dimension Vista System StreamLAB Analytical Workcell. Dimension Vista System Part Numbers 1000035896, 1000035899, 1000036563, and 1000036567. StreamLAB Analytical Workcell Part Number 746002.901, for in vitro diagnostic use.
- Status
- Terminated
- Initiated
- 2009-09-01
- Posted
- 2010-03-24
- Terminated
- 2010-09-15
- Reason
- Incorrect result: An intermittent low result may be seen with the last test run from an aliquot on a Dimension Vista System when connected to a StreamLAB Analytical Workcell. The sample delivery sequence may deliver insufficient surplus volume to the low sensitivity aliquot (second aliquot). The surplus sample volume is occasionally insufficient to and can cause short sampling on the last test.
- Root cause
- Software design
- Action
- Siemens healthcare Diagnostics issued an Urgent Field Safety Notice letter to each customer regarding the issue dated September 2009. The letter informed the user of the problem and volume change instructions. Customers can call Technical Solutions Center at 800-441-9250
- Quantity
- 81 units
- Distribution
- Worldwide distribution: USA, Australia, Canada, France, Germany, Malaysia, Netherlands, Spain, and Switzerland.
- Lot, serial or model codes
- Dimension Vista System Part Numbers 1000035896, 1000035899, 1000036563, and 1000036567. StreamLAB Analytical Workcell Part Number 746002.901 ***All StreamLAB Analytical Workcells connected to Dimension Vista Systems.
- 510(k) numbers
- ["K043546","K051087"]
- PMA numbers
- not on file
- Product code
- CDT
- 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