ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Reported: August 18, 2021 Initiated: June 24, 2021 #Z-2226-2021
Product Description
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Reason for Recall
Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
Details
- Recalling Firm
- Biomerieux Inc
- Units Affected
- 1,431
- 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.
- Location
- Hazelwood, MO
Frequently Asked Questions
What product was recalled? ▼
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic. Recalled by Biomerieux Inc. Units affected: 1,431.
Why was this product recalled? ▼
Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 18, 2021. Severity: Moderate. Recall number: Z-2226-2021.
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