ETEST IMIPENEM RELEBACTAM. in vitro diagnostic recall
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Why was ETEST IMIPENEM RELEBACTAM. in vitro diagnostic recalled?
Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
- Recalling firm
- Biomerieux Inc
- 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, Germany, Greece, Italy, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland and United Kingdom.
- Recall date
- August 18, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)