FDA recall Z-2226-2021

Product

ETEST IMIPENEM RELEBACTAM. in vitro diagnostic

Reason for recall

Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.

Distribution

Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii. The countries of Austria, Belgium, Croatia, Czech Republic, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland and United Kingdom.

Key facts

Status

Terminated

Initiation date

2021-06-24

Report date

2021-08-18

Termination date

2025-02-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hazelwood, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2226-2021