Microbiologics Inc recalls Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use

Recall date

January 31, 2019

Source

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

Recall number

Z-0982-2019

FDA classification

Class II

Brand / firm

Microbiologics Inc

Sold / distributed

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI, WV. International distribution to Austria, Canada, Finland, Ireland, Malaysia, New Zealand, Portugal, South Africa, Sweden, Swit…

Why it was recalled

Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.

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 Respiratory Control Panel Catalog #8199 for in vitro diagnostic use