FDA Device recall Z-1926-2014
Siemens Dimension LOCI TNI Troponin I Calibrator RC 621
- FDA Device
- Class II
- terminated
- Published 2014-07-02
On 2014-07-02 the FDA classified a Class II recall of Siemens Dimension LOCI TNI Troponin I Calibrator RC 621 by Siemens Healthcare Diagnostics, citing siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1926-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-17 |
| Published | 2014-07-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
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.
Reason
Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration.
Identifiers
| code_info | Lot Number - 3DD007 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1926-2014%22
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