Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.

Reason: Product with incorrect shelf life.

Code information: Cepheid Xpert MRSA/MRSA NxG Control Panel Catalog Number 8195 Lot Numbers: 8195-02, 8195-03, 8195-04, 8195-05, 8195-06, 8195-07, 8195-08, 8195-09, and 8195-10. Cepheid Xpert¿ SA Nasal Complete Control Panel Catalog Number 8196 Lot Numbers: 8196-04, 8196-05, 8196-06, 8196-07, 8196-08 8196-09, 8196-10, and 8196-14.

Distribution pattern: Worldwide Distribution - US Nationwide AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, MI, MO,MS, MT, NC, ND, NJ, NY, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WV, and WY. Australia, Chile, Germany, New Zealand, and United Kingdom.