Recalls / —
—#106113
Product
Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085, in vitro diagnostic
- FDA product code
- JIT — Calibrator, Secondary
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K081683
- Affected lot / code info
- Lot number 1DD085
Why it was recalled
Siemens Healthcare Diagnostics has confirmed positive bias on QC and Patients.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Address
- 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2011-11-17
- Posted by FDA
- 2012-01-11
- Terminated
- 2014-08-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #106113. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.