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.
Reported: July 2, 2014 Initiated: September 17, 2013 #Z-1926-2014
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.
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 1625
- Distribution
- Distribution: US Nationwide including Puerto Rico
- Location
- Newark, DE
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 1625.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on July 2, 2014. Severity: Moderate. Recall number: Z-1926-2014.
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