Microbiologics Inc recalls Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbio…

Recall date

April 9, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1730-2019

FDA classification

Class II

Brand / firm

Microbiologics Inc

Sold / distributed

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.

Why it was recalled

Product with incorrect shelf life.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.