FDA recall Z-1838-2019

Microbiologics Inc · Class III · device

Product

Cepheid Xpert C. difficile/Epi Control Panel

Reason for recall

Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.

Distribution

NY, MN, NC, TX, GA, MO, PA, TN, NH, OH, CO

Key facts

Status
Ongoing
Initiation date
2019-05-16
Report date
2019-06-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Cloud, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1838-2019