Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac… recallZ-0513-2012 · Siemens Healthcare Diagnostics, Inc. · initiated Nov 17, 2011
Terminated All recalls posted in January 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Siemens Healthcare Diagnostics has confirmed positive bias on QC and Patients.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0513-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 17, 2011
- Posted by the FDA
- Jan 11, 2012
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 2281 cartons
- Product code
- JIT
- FDA submissions
- K081683
- 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.
Product description
Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085, in vitro diagnostic
Code information (models, lots, serial numbers)
Lot number 1DD085
Other devices under the same FDA submission
1 device cleared under K081683 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dimension® TNI CAL 10464336Siemens Healthcare Diagnostics Inc. · CALIBRATOR, SECONDARY1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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