Recalls / —
—#188207
Product
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
- FDA product code
- JWY — Manual Antimicrobial Susceptibility Test Systems
- Device class
- Class 2
- Medical specialty
- Microbiology
- 510(k) numbers
- K191953
- Affected lot / 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
Why it was recalled
Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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 false resistant/intermediate results that may have occurred, to analyze the related risks and to determine appropriate actions if relevant.
Recalling firm
- Firm
- Biomerieux Inc
- Address
- 595 Anglum Rd, Hazelwood, Missouri 63042-2320
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2021-06-24
- Terminated
- 2025-02-10
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #188207. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.