Dimension Vista Chemistry 2 Calibrator, Catalog number KC120. Used to calibrate Phosphate, Salicylate, and Triglycerides
FDA device recall Z-2387-2010 · posted 2010-09-09 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- There is incorrect barcode information, which can potentially cause the Alert Message "Calibrator Insert Missing" to be displayed.
- Action taken
- The recalling firm issued an Urgent field Safety Notice, dated February 2010, to all affected customers informing them of the problem. Customers have been told to run calibrators from cups when calibrating or request a replacement lot. The notification should be forwarded to that this product was further distributed to. Siemens Technical Solutions Center should be contacted at 800-441-9250, if they are any technical questions.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JIX
- Quantity affected
- 1310 cartons
- Distribution
- Worldwide Distribution -- USA, Austria, Germany, Netherlands, Italy, France, Denmark, Portugal, Canada, South Korea, Malaysia, Australia, and New Zealand.
- Date initiated
- 2010-02-26
- Date posted
- 2010-09-09
- Date terminated
- 2010-10-13
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120) (K061703) | Dade Behring, Inc. | 2006-08-02 |