ID NOW Strep A 2 734-000Recalls & reported problems

Alere Scarborough, Inc. · A rapid, automated, molecular test for the qualitative detection of Streptococcus pyogenes Group A bacterial nucleic acid in throat swab specimens. · Class 2

Data updated Oct 18, 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 10811877010552), received between Dec 14, 2019 and Dec 14, 2019 — classified as 1 malfunction.

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 18, 2026.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

No Information1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

MalfunctionDec 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CUSTOMER REPORTED THE STERILE THROAT SWAB PROVIDED IN THE ID NOW STREP A 2 KIT BREAKING IN A PEDIATRIC MALE PATIENT'S MOUTH. THE CUSTOMER STATED THAT THE PATIENT BIT DOWN DURING THE SAMPLE COLLECTION AND THE PLASTIC SHAFT OF THE SWAB BROKE. THE BROKEN PLASTIC SWAB SHAFT WENT DOWN THE PATIENT'S THROAT AND WAS THEN EXPELLED WHEN THE PATIENT VOMITED. THE CUSTOMER STATED THE PATIENT WAS NOT INJURED AND DID NOT REQUIRE TREATMENT. THE CUSTOMER DID NOT REPORT ANY PROBLEMS WITH THE ID NOW STREP A 2 ASSAY; THE COMPLAINT IS EXCLUSIVELY CONCERNING THE STERILE COLLECTION SWAB PROVIDED IN THE ASSAY KIT. THE STERILE COLLECTION SWABS PROVIDED IN THE ID NOW STREP A 2 KIT ARE MANUFACTURED BY (B)(4) AND RECEIVED AT ABBOTT DIAGNOSTICS (B)(4) WHERE THEY ARE INSPECTED AND THEN ADDED TO THE ASSAY KITS. (B)(4) (MANUFACTURER) WAS NOTIFIED BY ABBOTT DIAGNOSTICS (B)(4) OF THE COMPLAINT.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 9470625 ↗

Device details

UDI-DI	`10811877010552`
Brand	ID NOW Strep A 2
Model	734-000
Company	Alere Scarborough, Inc.
Product code	PGX · Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Class	Class 2
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	Sep 12, 2023

Device type (GMDN): Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen, using a nucleic acid technique (NAT).

Other Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System devices

Xpert Xpress Strep A XPRSTREPA-10
Cepheid · Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
1 recall0 reports

All Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System devices →

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 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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