RAPID ID 32 ERecalls & reported problems

Biomerieux SA · rapid ID 32 E is a standardized system for the identification of Enterobacteriaceae in 4 hours · 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 03573026588649), received between Aug 21, 2020 and Aug 21, 2020 — 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 Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 21, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
AN INDUSTRY CUSTOMER IN (B)(6)NOTIFIED BIOMÉRIUX OF A MISIDENTIFICATION OF CRONOBACTER STRAINS AS ENTEROBACTER CLOACAE SPECIES IN ASSOCIATION WITH THE API® RAPID ID 32 E 25STRIPS (REF. (B)(4), LOT. 1007739570) WHEN TESTING COLONIES ORIGINALLY SOURCED FROM MILK POWDER. THE SAMPLE WAS TESTED USING GENE-UP WHICH OBTAINED A CRO POSITIVE RESULT. THE ORGANISM WAS THEN SUBCULTURED ONTO ESIA AGAR BLUE-GREEN COLONIES WERE OBSERVED INDICATING CRONOBACTER. THEN COLONIES WERE SUBCULTURED ON A NUTRITIVE AGAR AND THE CONFIRMATION OF THE IDENTIFICATION PERFORMED WITH THE IMPACTED LOT OF RAPID ID 32 E STRIPS THAT GAVE ENTEROBACTER CLOACAE SPECIES INSTEAD OF CRONOBACTER AS EXPECTED. AS THERE IS NO PATIENT ASSOCIATED WITH THIS INDUSTRY STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.
Patient problems: No Patient Involvement
MAUDE report 10437425 ↗

Device details

UDI-DI	`03573026588649`
Brand	RAPID ID 32 E
Model	RAPID ID 32 E
Company	Biomerieux SA
Product code	JSS · KIT, IDENTIFICATION, ENTEROBACTERIACEAE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 12, 2024

Device type (GMDN): Multiple gram negative bacteria species culture isolate identification IVD, kit

A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of gram negative bacteria belonging to the Enterobacteriaceae or non-Enterobacteriaceae families, that have been isolated by culture from a clinical specimen.

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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.

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