Recall Z-0139-2011 ยท CEM Electrode, Ion Specific, Potassium
Siemens Healthcare Diagnostics, Inc.
Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on the Dimension vista System.
| Date | Oct 25, 2010 (initiated Aug 19, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 3,706 cartons |
| Distribution | USA, Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051087 | DIMENSION VISTA INTEGRATED SYSTEM Dade Behring, Inc., Jul 11, 2005 |