ETEST Benzylpenicillin (PG)Recalls & reported problems across all models
Biomerieux SA · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one ETEST Benzylpenicillin (PG) model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 3 models of ETEST Benzylpenicillin (PG) by Biomerieux SA in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Mar 26, 2020 and Mar 27, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
ETEST Benzylpenicillin (PG) recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 9, 2022Open, Classified
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0820-2023 · Root cause: Storage · Recall details · FDA record ↗
Most reported ETEST Benzylpenicillin (PG) problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings4
Patient problems
- No Patient Involvement3
- No Known Impact Or Consequence To Patient1
ETEST Benzylpenicillin (PG) models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ETEST® Benzylpenicillin (PG)Manual Antimicrobial Susceptibility Test Systems1 recall0 reports
- ETEST® Benzylpenicillin (PG)Manual Antimicrobial Susceptibility Test Systems3 reports
- ETEST® Benzylpenicillin (PG)Manual Antimicrobial Susceptibility Test Systems1 report
Recent ETEST Benzylpenicillin (PG) adverse event reports
The 4 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF OUT-OF-RANGE HIGH BENZYLPENICILLIN RESULTS FOR ENTEROCOCCUS FAECALIS ATCC 29212 WHEN PERFORMING INTERNAL QUALITY CONTROL TESTING WITH THE ETEST BENZYLPENICIL PG 32 US S30 (REF. (B)(4), LOT 1007645640). THE CUSTOMER OBTAINED A MIC OF 32 MG/L (RESISTANT) AND THE EXPECTED RANGE FOR ENTEROCOCCUS FAECALIS ATCC 29212 IS 1 - 4 MG/L (SUSCEPTIBLE). AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMERIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.
Patient problems: No Patient Involvement
MAUDE report 9890707 ↗MalfunctionMar 27, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OUT-OF-RANGE HIGH BENZYLPENICILLIN RESULTS FOR ENTEROCOCCUS FAECALIS ATCC® 29212¿ WHEN PERFORMING INTERNAL QUALITY CONTROL TESTING WITH THE ETEST® BENZYLPENICIL PG 32 US F100 (REF 502658, LOT 1007477190). THE CUSTOMER OBTAINED A MIC OF 32 MG/L (RESISTANT) AND THE EXPECTED RANGE FOR ENTEROCOCCUS FAECALIS ATCC® 29212¿ IS 1 - 4 MG/L (SUSCEPTIBLE). AS THE CUSTOMER WAS PERFORMING INTERNAL QC TESTING, THERE IS NO PATIENT INVOLVED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.
Patient problems: No Patient Involvement
MAUDE report 9888194 ↗MalfunctionMar 26, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A CUSTOMER IN UNITED STATES NOTIFIED BIOMÉRIEUX OF OUT-OF-RANGE HIGH BENZYLPENICILLIN RESULTS FOR ENTEROCOCCUS FAECALIS ATCC® 29212¿ WHEN PERFORMING INTERNAL QUALITY CONTROL TESTING WITH THE ETEST® BENZYLPENICIL PG 32 US F100 (REF 502658, LOT 1007341070). THE CUSTOMER OBTAINED A MIC OF 32 MG/L (RESISTANT) AND THE EXPECTED RANGE FOR ENTEROCOCCUS FAECALIS ATCC® 29212¿ IS 1 - 4 MG/L (SUSCEPTIBLE). AS THE CUSTOMER WAS PERFORMING INTERNAL QC TESTING, THERE IS NO PATIENT INVOLVED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.
Patient problems: No Patient Involvement
MAUDE report 9886020 ↗MalfunctionMar 26, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OUT-OF-RANGE HIGH BENZYLPENICILLIN RESULTS FOR ENTEROCOCCUS FAECALIS ATCC® 29212¿ WHEN PERFORMING INTERNAL QUALITY CONTROL TESTING WITH THE ETEST® BENZYLPENICIL PG 32 US F100 (REF 502658, LOT 1007645760). THE CUSTOMER OBTAINED A MIC OF 32 MG/L (RESISTANT) AND THE EXPECTED RANGE FOR ENTEROCOCCUS FAECALIS ATCC® 29212¿ IS 1 - 4 MG/L (SUSCEPTIBLE). AS THE CUSTOMER WAS PERFORMING INTERNAL QC TESTING, THERE IS NO PATIENT INVOLVED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9885898 ↗
Other Biomerieux SA products
All Biomerieux SA devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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