Biomerieux Inc Recall 88242
Description: ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Biomerieux Inc Recall 88242 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2226-2021 |
| Event ID | 88242 |
| Event Description | ETEST IMIPENEM RELEBACTAM. in vitro diagnostic |
| Product Type | Devices |
| 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. |
| Quantity | 1,431 |
| Recall Reason | Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains. |
| Device Classification | 20210818 |
| Device Code Info | Ref 420927 (US Product) Lot numbers 1007888860, 1008598340, 1008701580, 1007607290, 1007888870, 1008390030, 1008598350 and 1008701590 and Ref 420925 (not distributed in US):Lot Codes: 1007888860, 100859840 and 1008701580 |
| Center Classification Date | 20210806 |
| Recall Initiation Date | 20210624 |
| Recalling Firm | Biomerieux Inc |
| Initial Notification | Letter |
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