FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 The Dimension Vista CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN) and Uric Acid (URCA) methods on the Dimension Vista System
- Recall number
- Z-0864-2010
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 The Dimension Vista CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN) and Uric Acid (URCA) methods on the Dimension Vista System
- Status
- Terminated
- Initiated
- 2009-08-31
- Posted
- 2010-02-26
- Terminated
- 2010-12-13
- Reason
- Siemens Healthcare Diagnostics, Inc. has confirmed high accuracy shifts with Dimension Vista URCA Flex reagent cartridge (various lots) when calibrating with some vials from CHEM 1 calibrator lot 9DM001.
- Root cause
- Other
- Action
- An Urgent Field Safety Notice dated August 31, 2009, was issued to all affected customers. Customers were instructed to discontinue the use of Dimension Vista System CHEM 1 Cal lot 9DM001 and discard any remaining product. If customers have any question they can contact Technical Solutions at 1-800-241-0420.
- Quantity
- 1474 Cartons
- Distribution
- Nationwide and Foreign: Australia, Canada, Denmark, and Malaysia.
- Lot, serial or model codes
- Lot Number 9DM001
- 510(k) numbers
- ["K061838"]
- PMA numbers
- not on file
- Product code
- JIX
- 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