Recall Z-2226-2021 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Biomerieux Inc
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
| Date | Jun 24, 2021 |
| Status | Terminated |
| Reason | Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains. |
| Root cause | Under Investigation by firm |
| Action | The recall notification was issued to the impacted subsidiaries and distributors on 24JUN2021. The notification includes a Customer Letter to be translated into local language and sent to each impacted customer. The customer letter will inform the customers about the MIC overestimation and false resistant results issue and will be instructed to: - Perform a retest using an alternative method on P. aeruginosa strains for which they obtained resistant or intermediate results with ETEST IMIPENEM RELEBACTAM ref. 420925 and 420927 - Among tests previously performed, identify any possible fa |
| Quantity | 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, German |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191953 | ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) Biomerieux S.A., Aug 22, 2019 |