Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085, in vitro diagnostic
FDA device recall Z-0513-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Siemens Healthcare Diagnostics has confirmed positive bias on QC and Patients.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JIT
- Quantity affected
- 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 Swit
- Date initiated
- 2011-11-17
- Date posted
- 2012-01-11
- Date terminated
- 2014-08-26
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 (K081683) | Siemens Healthcare Diagnostics | 2008-07-07 |