Recall Z-1926-2014 ยท JIT Calibrator, Secondary
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Jun 26, 2014 (initiated Sep 17, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| 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) 44 |
| Quantity | 1625 |
| Distribution | Distribution: US Nationwide including Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081683 | LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 Siemens Healthcare Diagnostics, Jul 7, 2008 |