Beckman Coulter Inc. recalls Access hsTnI High Sensitivity Troponin I, REF B52699 Acce
Recalled Product
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Hazard / Issue
Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover predominantly into the particle well of the reagent pack by way of the probe. The particle well then becomes contaminated by the high sample from the probe. The extent of the carryover is dependent on sample concentration and frequency of high concentration samples.
Issued by
FDA
Affected States: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, ME, MD, MI, MN, MS, MO, NC, ND, NE, NV, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, WV, WY