ETEST® Benzylpenicillin (PG) (UDI 03573026548698)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03573026548698), received between Mar 26, 2020 and Mar 27, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K981135); 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, 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 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K981135. One submission often covers many models, so check the product and lot details in each record.

• Z-0820-2023 · Nov 9, 2022 · Open, Classified
  ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262
• Z-1527-2017 · Dec 15, 2016 · Terminated
  ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG 0.016-256 (high). ETEST is a quantitative technique for determining the antimicrobial suscepti