OSOM Ultra Strep A 25 Test Kit 147Recalls & reported problems
Sekisui Diagnostics, LLC · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00742860001475), received between Oct 22, 2025 and Oct 22, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (2 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- Laceration(s)2
- Bruise/Contusion1
- Hemorrhage/Blood Loss/Bleeding1
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 22, 2025Fracture; Fracture
WHEN TRYING TO BREAK THE REAGENT VIAL PRIOR TO USE (GLASS AMPOULE INSIDE A PLASTIC AMPOULE), IT WAS REPORTED THAT THE GLASS POKED THROUGH THE PLASTIC AND CUT THE USER'S HAND. THERE WAS A SMALL CUT THAT BLED, WHICH WAS TREATED BY FLUSHING WITH WATER. THE INJURED AREA SEEMED TO REACT TO THE CHEMICALS IN THE REAGENTS, AND SHE ENDED UP WITH SWELLING, BRUISING, AND PAIN. THE USER WENT TO URGENT CARE AT THE END OF THE DAY AND WAS PRESCRIBED AN ANTIBIOTIC, DOXYCLYCLINE. IT WAS CONFIRMED THAT THERE WAS NO GLASS STUCK IN THE USER'S HAND. IT WAS REPORTED THAT EVERYTHING WAS FINE AND THE ANTIBIOTIC WAS A PREVENTATIVE "JUST IN CASE" TREATMENT FOR THE IRRITATION.
Patient problems: Bruise/Contusion; Hemorrhage/Blood Loss/Bleeding; Laceration(s); Pain; Swelling/ Edema
MAUDE report 23357741 ↗MalfunctionOct 22, 2025Fracture; Fracture
WHEN TRYING TO BREAK THE REAGENT VIAL PRIOR TO USE (GLASS AMPOULE INSIDE A PLASTIC AMPOULE), IT WAS REPORTED THAT THE GLASS POKED THROUGH THE PLASTIC, RESULTING IN A SCRATCH WITHOUT BLOOD. ADDITIONAL INFORMATION INDICATED THAT THERE WAS NO TREATMENT PERFORMED OUTSIDE OF BASIC FIRST AID (FLUSH/RINSE AREA FOR 15 MINUTES AND APPLY BANDAGE/BAND AID).
Patient problems: Laceration(s)
MAUDE report 23357740 ↗
Other ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. devices
- BD Veritor™ System for Rapid Detection of Group A Strep CLIA-Waived Kit 256040Becton, Dickinson And Company · ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.258 reports
- Acceava® 92001Alere San Diego, Inc. · Antigens, All Groups, Streptococcus Spp.2 recalls2 reports
- QuickVue 20108Quidel Corporation · ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.2 recalls0 reports
- Sofia 20274Quidel Corporation · ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.1 recall2 reports
- Clearview® 92002Alere San Diego, Inc. · Antigens, All Groups, Streptococcus Spp.1 recall1 report
- QuickVue In-Line 00345Quidel Corporation · ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.1 recall0 reports
- McKesson 5003Mckesson Medical-Surgical Inc. · Antigens, All Groups, Streptococcus Spp.1 recall0 reports
- McKesson 4999Mckesson Medical-Surgical Inc. · Antigens, All Groups, Streptococcus Spp.1 recall0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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