ID 32 STAPHRecalls & reported problems
Biomerieux SA · ID 32 STAPH is a standardized system for the identification of the genera Staphylococcus, Micrococcus and related genera, Rothia and Aerococcus · Class 1
Data updated Oct 13, 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 03573026588601), received between Aug 12, 2021 and Aug 12, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
PRODUCT INTENDED USE: ID 32 STAPH IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF THE GENERA STAPHYLOCOCCUS, MICROCOCCUS AND RELATED GENERA, ROTHIA AND AEROCOCCUS. IT USES MINIATURIZED TESTS AS WELL AS A SPECIALLY ADAPTED DATABASE. AFTER MANUAL INOCULATION OF THE STRIP, READING CAN BE PERFORMED EITHER AUTOMATICALLY OR MANUALLY AND THE IDENTIFICATION IS OBTAINED USING AN IDENTIFICATION SOFTWARE. DESCRIPTION OF THE ISSUE: A CUSTOMER FROM (B)(6) REPORTED THAT API® STRIP ID 32 STAPH (REF. 32500, LOT 1008439200) DID NOT WORK CORRECTLY DURING READING WITH APIWEB¿ (IDENTIFICATION SOFTWARE). THE CUSTOMER REPORTED THAT ON (B)(6) 2021, MULTIPLE REAGENT STRIPS DISPLAYED INCORRECT INFORMATION ON THE SYSTEM, AND BACTERIAL IDENTIFICATION COULD NOT BE PERFORMED. NO DETAILS WERE PROVIDED REGARDING THE INCORRECT INFORMATION DISPLAYED; HOWEVER, IN THE WORST CASE SCENARIO, AN INCORRECT ORGANISM IDENTIFICATION CAN BE SUSPECTED. THERE IS NO INDICATION FROM THE CUSTOMER THAT THIS EVENT LED TO A DELAY OF RESULT OR IMPACTED THE PATIENT STATE OF HEALTH. THE CUSTOMER INDICATED HE REPORTED THIS INCIDENT TO (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12313669 ↗
Other KIT, SCREENING, STAPHYLOCOCCUS AUREUS devices
- API® Staph 20500Biomerieux SA · KIT, SCREENING, STAPHYLOCOCCUS AUREUS1 recall1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page