ETEST® Ceftaroline (CPT)Recalls & reported problems
Biomerieux SA · Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026547509), received between Oct 6, 2017 and Oct 6, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Incorrect Or Inadequate Test Results1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 6, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results
A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF AN "ODD RESULT" ASSOCIATED WITH ETEST® CEFTAROLINE CPT 32 US B30 (REFERENCE 537540). THE ISSUE CAME UP DURING TESTING OF A QUALITY CONTROL SAMPLE. ANOTHER TEST FROM A DIFFERENT LOT WAS OPENED AND THE TEST RUN APPROPRIATELY. THERE IS NO PATIENT INVOLVED THIS EVENT OCCURRED DURING A QUALITY CONTROL TEST. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.
Patient problems: No Patient Involvement
MAUDE report 6921539 ↗
Other Manual Antimicrobial Susceptibility Test Systems devices
- ETEST® Imipenem/Relebactam (IPR)Biomerieux SA · Manual antimicrobial susceptibility test systems1 recall4 reports
- ETEST® Amikacin (AK)Biomerieux SA · Manual Antimicrobial Susceptibility Test Systems1 recall2 reports
- ETEST® Tobramycin (TM)Biomerieux SA · Manual Antimicrobial Susceptibility Test Systems1 recall1 report
- ETEST® Erythromycin (EM)Biomerieux SA · Manual Antimicrobial Susceptibility Test Systems1 recall0 reports
- ETEST® Rifampicin (RI)Biomerieux SA · Manual Antimicrobial Susceptibility Test Systems1 recall0 reports
- ETEST® Eravacycline (ERV)Biomerieux SA · Manual antimicrobial susceptibility test systems1 recall0 reports
- ETEST® Benzylpenicillin (PG)Biomerieux SA · Manual Antimicrobial Susceptibility Test Systems1 recall0 reports
- ETEST® Ampicillin (AM)Biomerieux SA · Manual Antimicrobial Susceptibility Test Systems1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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