BinaxNOW Strep A Card 730-025Recalls & reported problems

Alere Scarborough, Inc. · A rapid test for the qualitative detection of Streptococcus pyogenes Group A antigen from throat swab specimens. · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

Aug 20, 2024Class IIOpen, Classified
Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Z-3184-2024 · Root cause: Process control · Recall details · FDA record ↗

Device details

UDI-DI	`10811877010453`
Brand	BinaxNOW Strep A Card
Model	730-025
Company	Alere Scarborough, Inc.
Product code	GTZ · Antisera, All Groups, Streptococcus Spp.
Class	Class 1
FDA submission	K960712
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 9, 2023

Device type (GMDN): Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Other Antisera, All Groups, Streptococcus Spp. devices

OSOM Strep A 50 Test Kit 141
Sekisui Diagnostics, LLC · ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
1 report
AURORA® Surgiscope® AS8/130
Rebound Therapeutics Corporation · ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
1 report

All Antisera, All Groups, Streptococcus Spp. 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
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
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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