ETEST® Fosfomycin (FM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03573026547196), received between Dec 7, 2021 and Dec 7, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K981136); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE USA NOTIFIED BIOMÉRIEUX OF OBTAINING QC FAILURE (OUT-OF-RANGE-HIGH RESULTS) IN ASSOCIATION WITH FOSFOMYCIN FM 1024 US B30 - (REF: 529140, LOT 1008857310, EXPIRATION DATE 17/07/2022) REGARDING AN ATCC® STRAIN. THEY REPORTED BOTH LOT 1008857310 AND 1008200670 WERE NOT PASSING QC FOR PSEUDOMONAS AERUGINOSA ATCC® 27853¿: THE EXPECTED MIC RESULTS WERE BETWEEN 2 AND 8 AND THE CUSTOMER IS GETTING 32. THEY RERAN THE TEST SIX DIFFERENT TIMES AND STATED THEY STILL DID NOT GET THE CORRECT RESULT. THIS COMPLAINT IS AGAINST THE LOT 1008857310. THE CUSTOMER RETESTED THE STRAIN FOLLOWING THE METHODOLOGY AND STORAGE GUIDANCE PROVIDED BY BIOMÉRIEUX AND THE QC WITH ATCC 27853 IS STILL OUT OF RANGE HIGH (MIC OF 12-16-24, INSTEAD OF 2-8). NO DELAYED RESULTS RELATED TO THIS QC FAILURE HAVE BEEN REPORTED BY THE CUSTOMER. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QC STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE CONDUCTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12955080 ↗
• MalfunctionDec 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE USA NOTIFIED BIOMÉRIEUX OF OBTAINING QC FAILURE (OUT-OF-RANGE-HIGH RESULTS) IN ASSOCIATION WITH FOSFOMYCIN FM 1024 US B30 - (REF: 529140, LOT 1008857310, EXPIRATION DATE 17/07/2022) REGARDING AN ATCC® STRAIN. THEY REPORTED BOTH LOT 1008857310 AND 1008200670 WERE NOT PASSING QC FOR PSEUDOMONAS AERUGINOSA ATCC® 27853¿: THE EXPECTED MIC RESULTS WERE BETWEEN 2 AND 8 AND THE CUSTOMER IS GETTING 32. THEY RERAN THE TEST SIX DIFFERENT TIMES AND STATED THEY STILL DID NOT GET THE CORRECT RESULT. THIS COMPLAINT IS AGAINST THE LOT 1008857310. THE CUSTOMER RETESTED THE STRAIN FOLLOWING THE METHODOLOGY AND STORAGE GUIDANCE PROVIDED BY BIOMÉRIEUX AND THE QC WITH ATCC 27853 IS STILL OUT OF RANGE HIGH (MIC OF 12-16-24, INSTEAD OF 2-8). NO DELAYED RESULTS RELATED TO THIS QC FAILURE HAVE BEEN REPORTED BY THE CUSTOMER. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QC STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE CREATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12955064 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K981136. One submission often covers many models, so check the product and lot details in each record.

• Z-1528-2017 · Dec 15, 2016 · Terminated
  ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-