—#122157

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.

FDA product code: JIT — Calibrator, Secondary
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K081683
Affected lot / code info: Lot Number - 3DD007

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Distribution: US Nationwide including Puerto Rico

Timeline

Recall initiated: 2013-09-17
Posted by FDA: 2014-06-26
Terminated: 2014-08-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122157. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.