In Vitro Diagnostic Test Produces Incorrect Antibiotic Susceptibility Results
Biomerieux's ETEST IMIPENEM RELEBACTAM diagnostic test produces major errors when testing Pseudomonas aeruginosa, incorrectly identifying resistant strains as susceptible. Approximately 1,431 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA medical device recall where the diagnostic test produces incorrect antibiotic susceptibility results for Pseudomonas aeruginosa, a high-risk pathogen. While no illnesses or injuries have been reported, the risk of diagnostic error leading to inappropriate antibiotic therapy represents significant potential for patient harm.
Plain-English summary
Biomerieux Inc is recalling the ETEST IMIPENEM RELEBACTAM in vitro diagnostic test, which is used to determine bacterial susceptibility to the antibiotic combination imipenem and relebactam.
The recall was issued because the test produces major errors when testing Pseudomonas aeruginosa strains, incorrectly reporting resistant bacteria as susceptible. This diagnostic error could lead to inappropriate antibiotic selection and potentially ineffective treatment.
Approximately 1,431 units have been affected. The test was distributed nationwide across the United States and internationally to Austria, Belgium, Croatia, Czech Republic, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, and the United Kingdom.
Affected laboratories and healthcare facilities that have received the recalled test should verify lot numbers against the FDA notice and discontinue use of affected units.
The recalled product
- Product
- ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
- Manufacturer
- Biomerieux Inc
- Affected units
- 1,431
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Ref 420927 (US Product) Lot numbers 1007888860
- 1008598340
- 1008701580
- 1007607290
- 1007888870
- 1008390030
- 100859840 and 1008701580
Distribution
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