CLASS II Device recall · Reported 2 Jul 2014 · FDA Enforcement Report
Siemens Dimension LOCI TNI Troponin I Calibrator RC recalled
Siemens Healthcare Diagnostics is recalling Siemens Dimension LOCI TNI Troponin I Calibrator RC 621, distributed nationwide in the US. The recall was initiated on 17 Sep 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1926-2014
- FDA event ID
- 66364
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Sep 2013
- FDA classified
- 26 Jun 2014
- Reported
- 2 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 17 Sep 2013 | Recall initiated by company | |
| 26 Jun 2014 | Classified by FDA | +282 days |
| 2 Jul 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration.
Product as listed by the FDA
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.
Where it was distributed
Distribution: US Nationwide including Puerto Rico
Questions about this recall
Why was it 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.
Which lots are affected?
Lot Number - 3DD007
Where was it sold?
Distribution: US Nationwide including Puerto Rico
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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