Sofia 20274Recalls & reported problems
Quidel Corporation · Sofia Strep A+ 25T, US · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30014613202745), received between May 8, 2018 and Aug 25, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Chemical Spillage” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- May 25, 2022Open, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1598-2022 · Root cause: Environmental control · FDA record ↗
Most reported problems
Device problems
- Chemical Spillage1
- Material Rupture1
Patient problems
- Needle Stick/Puncture1
- Red Eye(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2026Material Rupture
Patient problems: Needle Stick/Puncture
MAUDE report 50438178 ↗InjuryMay 8, 2018Chemical Spillage; Chemical Spillage
WHEN OPENING A STREP A REAGENT SOLUTION VIAL, THE SOLUTION SPLASHED INTO THE RIGHT EYE OF THE OPERATOR WHICH CAUSED STINGING AND BURNING. THE OPERATOR WENT TO A DOCTOR WHO PROVIDED ANTIBIOTIC EYE DROPS. THE EYE HEALED IN TWO DAYS.
Patient problems: Red Eye(s)
MAUDE report 7495325 ↗
Other ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. devices
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- QuickVue 20108Quidel Corporation · ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.2 recalls0 reports
- Clearview® 92002Alere San Diego, Inc. · Antigens, All Groups, Streptococcus Spp.1 recall1 report
- 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
- QuickVue In-Line 00345Quidel Corporation · ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.1 recall0 reports
- QuickVue 20125Quidel Corporation · ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.