Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 The Dimension Vista CHEM 1 CAL is an in vitro
FDA device recall Z-0864-2010 · posted 2010-02-26 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JIX
- Quantity affected
- 1474 Cartons
- Distribution
- Nationwide and Foreign: Australia, Canada, Denmark, and Malaysia.
- Date initiated
- 2009-08-31
- Date posted
- 2010-02-26
- Date terminated
- 2010-12-13
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110 (K061838) | Dade Behring, Inc. | 2006-08-21 |