Recall Z-0038-2012 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621) The LOCI Cardiac TNI Calibrator is an in vitro diagnostic product for the calibration on Cardiac Troponin I method on the Dimension(R) EXL (TM) Integrated chemistry system with LOCI(R) module.
| Date | Oct 12, 2011 (initiated Aug 31, 2011) |
| Status | Terminated |
| Reason | Internal testing has confirmed that recovery of levels 2 and 3 of LOCl Cardiac Troponin I Calibrator is lower than expected bottle value. Following calibration with LOCl Cardiac Troponin I Calibrator, lot 1AD045 an upward shift in patient and QC results may be observed. |
| Root cause | Other |
| Action | Siemens sent an Urgent Field Safety Notice dated August 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and discard any remaining inventory. Replacement orders would be processed and sent free of charge. Customers were also instructed to complete the attached FIELD CORRECTION EFFECTIVENESS CHECK form and fax it to (302) 631- 8457. Customers were instructed to forward the Safety Notice to anyone to whom they may have distributed the affected product. For an |
| Quantity | 998 |
| Distribution | Worldwide Distribution - USA (nationwide) including AL, AK, AZ, AR, CA, CO, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and the countries of GUAM, Austria, Canada, China, Czech Republic |
| 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 |