ETEST® Meropenem (MP) (UDI 03573026620011)Recalls & reported problems
Biomerieux SA · ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria · Class 2
All models of ETEST Meropenem (MP) (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K010363); they may or may not involve this specific model.
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.
Recalls naming this device
- Nov 9, 2022Open, Classified
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0859-2023 · Root cause: Storage · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K010363. One submission often covers many models, so check the product and lot details in each record.
- Z-0827-2023 · Nov 9, 2022 · Open, ClassifiedETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401
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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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