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.
FDA Recall Z-1926-2014 · Posted 2014-06-26
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJIT
Date Initiated2013-09-17
Date Terminated2014-08-27
Product Quantity1625
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.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Distribution: US Nationwide including Puerto Rico
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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