—#103938

Product

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.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K081683
Affected lot / code info: Lot Number 1AD045

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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 any technical questions customers were to contact the Siemens Solutions Center at 800-441-9250.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

Distribution pattern: 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, Egypt, France, Germany, Italy, Poland, Portugal, Puerto Rico, Spain and Switzerland.

Timeline

Recall initiated: 2011-08-31
Posted by FDA: 2011-10-12
Terminated: 2013-05-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103938. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.