Dimension Vista CHEM 3 calibrator is an in vitro diagnostic product for the calibration of ammonia (AMON), Cardon Dioxid
FDA device recall Z-1535-2010 · posted 2010-05-04 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- patient results are depressed
- Action taken
- An "Urgent Field Safety Notice" dated October 2009 was issued by Siemens to all customers. The notice described the product, problem and actions to be taken by the customers. The customers were instructed to recalibrate the AMON method (AMON Flex reagent cartridge, K3019) with Vista Chem 3 Claibrator lot 9ED058 using the revised bottle values provided in the notice and to please consult with their laboratory director regarding re-evaluation of previous results. The customers should forward this notification to anyone to whom they may have distributed this product. If you have any technical questions regarding this information, please contact Siemens Technical Solutions Center at 1-800-441-9250.
- Root cause
- Other
- Status
- Terminated
- Product code
- JIX
- Quantity affected
- 1753 cartons
- Distribution
- Worldwide distribution: USA and Australia, Canada, Japan, New Zealand, South Korea, and Switzerland.
- Date initiated
- 2009-10-23
- Date posted
- 2010-05-04
- Date terminated
- 2010-06-22
- Location
- Newark, DE
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130 (K062334) | Dade Behring, Inc. | 2006-09-22 |