OSOM Strep A 50 Test Kit 141Recalls & reported problems

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 00742860001413), received between Nov 12, 2019 and Nov 12, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Device Embedded In Tissue or Plaque1
Distress1

Recent adverse event reports

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

MalfunctionNov 12, 2019Adverse Event Without Identified Device or Use Problem
CUSTOMER SENT A LETTER TO SEKISUI STATING THAT DURING THE ROUTINE SWABBING OF A (B)(6) YEAR OLD CHILD, THE CHILD BIT DOWN ON THE SWAB AND A 6 CM PIECE BECAME LODGED IN THE CHILD'S THROAT. BEFORE THE PHYSICIAN COULD REMOVE THE SWAB, THE CHILD SWALLOWED THE SWAB. THE PARENTS WERE REQUIRED TO SIFT THROUGH THE CHILD'S FECES FOR A FEW DAYS UNTIL THE SWAB BIT WAS LOCATED. THE CHILD DID PASS THE SWAB AND THE PARENTS WERE ABLE TO FIND IT.
Patient problems: Device Embedded In Tissue or Plaque; Distress
MAUDE report 9313517 ↗

Device details

UDI-DI	`00742860001413`
Brand	OSOM Strep A 50 Test Kit
Model	141
Company	Sekisui Diagnostics, LLC
Product code	GTZ · ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
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	Jun 30, 2026

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

BinaxNOW Strep A Card 730-025
Alere Scarborough, Inc. · Antisera, All Groups, Streptococcus Spp.
1 recall0 reports
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 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