Recall Z-0513-2012 ยท JIT Calibrator, Secondary
Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085, in vitro diagnostic
| Date | Jan 11, 2012 (initiated Nov 17, 2011) |
| Status | Terminated |
| Reason | Siemens Healthcare Diagnostics has confirmed positive bias on QC and Patients. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens healthcare Diagnostics initiated their recall of lot 1DD085 on November 17, 2011 by sending an Urgent Field Safety Notice letter to all affected customers. Customers were requested to immediately discontinue use and discard any remaining inventory of the CTNI CAL lot 1DD085. |
| Quantity | 2281 cartons |
| Distribution | Worldwide distribution, including USA, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Puerto Rico, Slovenia, South Korea, Spain and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081683 | LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 Siemens Healthcare Diagnostics, Jul 7, 2008 |