FDA-Device2019-03-13Class II

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

Microbiologics Inc
Hazard

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

Sold states
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, Switzerland, United Kingdom.
Affected count
704 units
Manufactured in
200 Cooper Ave N, N/A, Saint Cloud, MN, United States
Products
Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0982-2019

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