Siemens Dimension LOCI TNI Troponin I Calibrator RC 621 recallZ-1926-2014 · Siemens Healthcare Diagnostics, Inc. · initiated Sep 17, 2013
Class II Terminated All recalls posted in June 2014
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 Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration.
FDA root cause category: Process control
What the company is doing
Siemens sent an Urgent Medical Device Recall letter dated September 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised immediate discontinuation of use and discard of the affected device. Please complete the attached Effectiveness Check form and fax it to the Siemens Customer Care Center at (302) 631-8467 to indicate that you have received this information. Also, please indicate any replacement product required. Please contact Siemens Customer Care Center- Technical Solutions at (800) 441 9250 if you are aware of any adverse event that occurred as a consequence of this issue, or for immediate product needs. Please retain this letter with your laboratory records, and forward this Jetter to those who may have received this product. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
Recall details
- Recall number
- Z-1926-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 17, 2013
- Posted by the FDA
- Jun 26, 2014
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 1625
- Product code
- JIT
- FDA submissions
- K081683
- Distribution
- Distribution: US Nationwide including Puerto Rico
Product description
Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL integrated chemistry system with LOCI module.
Code information (models, lots, serial numbers)
Lot Number - 3DD007
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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