Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on the Dimension vista System.
FDA device recall Z-0139-2011 · posted 2010-10-25 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- High potassium content in the affected lots results in the potential for low potassium recovery for Dilution Check, QC and patient samples when run on the Dimension Vista System.
- Action taken
- Siemens sent an Urgent Field Safety Notice (dated "August 2010") to customers identifying the product, the problem and the action to be taken. Customers were instructed on how to continue testing until new lots of the recalled product were available and asked to complete and fax a Field Correction Effectiveness Check to 301-631-8467 to confirm receipt of the Urgent Field Safety Notice. For technical questions or concerns customers were instructed to contact the Siemens Technical Solutions Center at 800-441-9250.
- Root cause
- Other
- Status
- Terminated
- Product code
- CEM
- Quantity affected
- 3,706 cartons
- Distribution
- USA, Nationwide Distribution
- Date initiated
- 2010-08-19
- Date posted
- 2010-10-25
- Date terminated
- 2010-10-26
- 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 INTEGRATED SYSTEM (K051087) | Dade Behring, Inc. | 2005-07-11 |