Sofia 20377Recalls & reported problems
Quidel Corporation · Sofia®2 Flu + SARS Antigen FIA · Class N
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Quidel Sofia 2 Flu and SARS antigen test is a rapid test for flu and COVID. Its 3,282 reports mostly describe the test giving false positive results, along with some false negatives. The reports include no deaths and 2 injuries. There is 1 open recall for this device, started in January 2024, over a batch of kits labeled with incorrect expiration dates.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 3,284
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3,284 adverse event reports that list this exact device (DI 30014613339229), received between Mar 1, 2022 and Sep 15, 2026 — classified as 2 injuries, 3,282 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (2,707 reports).
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
- Jan 3, 2024Open, Classified
One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The kits contain pouched cassettes labeled with an expiration date of May 31, 2025, however the correct expiration date for the pouches is September 12, 2024. The kits are labeled with an expiration date of April 30, 2025, however, the correct expiration date for the kits is September 12, 2024. The issue was discovered on November 28, 2023 by a supply chain employee who determined that the kits had expiration dates beyond the FDA authorized shelf life.
Z-1086-2024 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- No Apparent Adverse Event3,284
- False Positive Result2,707
- False Negative Result392
- Imprecise or Erratic Results172
- Incorrect, Inadequate or Imprecise Result or Readings6
- Non Reproducible Results6
- Device Handling Problem2
- High Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions3,255
- Insufficient Information201
Recent adverse event reports
The 25 most recent of 3,284 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026False Positive Result; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776391 ↗MalfunctionSep 15, 2026False Positive Result; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776380 ↗MalfunctionSep 15, 2026False Positive Result; No Apparent Adverse Event
Customer reported dual positive Influenza B and SARS result on three (3) occassions. Unknown confirmatory testing. Unknown if patient was symptomatic. Report 3 of 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776378 ↗MalfunctionJun 17, 2026False Positive Result; No Apparent Adverse Event
REPORTS INCREASE IN POSITIVE RESULTS FOR FLU B, NUMBER OF TESTS NOT SPECIFIED. CONFIRMATION NOT PERFORMED. NO OTHER INFORMATION PROVIDED. CUSTOMER LATER SAID THEY NO LONGER HAVE A CONCERN WITHOUT PROVIDING ADDITIONAL DETAILS. NO APPARENT ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25534974 ↗MalfunctionJun 17, 2026False Positive Result; No Apparent Adverse Event
REPORTS INCREASE IN POSITIVE RESULTS FOR FLU B, NUMBER OF TESTS NOT SPECIFIED. CONFIRMATION NOT PERFORMED. NO OTHER INFORMATION PROVIDED. CUSTOMER LATER SAID THEY NO LONGER HAVE A CONCERN WITHOUT PROVIDING ADDITIONAL DETAILS. NO APPARENT ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25534973 ↗MalfunctionJun 17, 2026False Positive Result; No Apparent Adverse Event
REPORTS INCREASE IN POSITIVE RESULTS, ANALYTE NOT SPECIFIED, NUMBER OF TESTS NOT SPECIFIED. CONFIRMATION NOT PERFORMED. PATIENTS WER SYMPTOMATIC. NO APPARENT ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25534972 ↗MalfunctionJun 10, 2026False Positive Result; No Apparent Adverse Event
REPORTS FALSE NEGATIVE FLU B RESULTS COMPLARED TO LABORATORY TEST METHOD. PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25465279 ↗MalfunctionJun 10, 2026False Positive Result; No Apparent Adverse Event
REPORTS FALSE NEGATIVE FLU B RESULTS COMPARED TO UNSPECIFIED MOLECULAR TEST. PATIENTS HAD NO SIGNIFICANT URI SYMPTOMS. NO APPARENT ADVERSE EVENT. REPORT 1 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25465277 ↗MalfunctionJun 10, 2026False Positive Result; No Apparent Adverse Event
REPORTS FALSE NEGATIVE FLU B RESULTS COMPARED TO UNSPECIFIED MOLECULAR TEST. PATIENTS HAD NO SIGNIFICANT URI SYMPTOMS. NO APPARENT ADVERSE EVENT. REPORT 2 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25465276 ↗MalfunctionJun 10, 2026False Positive Result; No Apparent Adverse Event
REPORTS FALSE NEGATIVE FLU B RESULTS COMPARED TO UNSPECIFIED MOLECULAR TEST. PATIENTS HAD NO SIGNIFICANT URI SYMPTOMS. NO APPARENT ADVERSE EVENT. REPORT 3 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25465275 ↗MalfunctionApr 7, 2026No Apparent Adverse Event; Imprecise or Erratic Results
REPORTS ERRATIC RESULTS ON 15 TESTS ACROSS ALL ANALYTES WHEN REUSING A SINGLE-USE DEVICE. UNKNOWN IF PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 15 OF 15.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808962 ↗MalfunctionApr 7, 2026No Apparent Adverse Event; Imprecise or Erratic Results
REPORTS ERRATIC RESULTS ON 15 TESTS ACROSS ALL ANALYTES WHEN REUSING A SINGLE-USE DEVICE. UNKNOWN IF PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 13 OF 15.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808959 ↗MalfunctionApr 7, 2026No Apparent Adverse Event; Imprecise or Erratic Results
REPORTS ERRATIC RESULTS ON 15 TESTS ACROSS ALL ANALYTES WHEN REUSING A SINGLE-USE DEVICE. UNKNOWN IF PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 12 OF 15.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808958 ↗MalfunctionApr 7, 2026No Apparent Adverse Event; Imprecise or Erratic Results
REPORTS ERRATIC RESULTS ON 15 TESTS ACROSS ALL ANALYTES WHEN REUSING A SINGLE-USE DEVICE. UNKNOWN IF PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 14 OF 15.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808957 ↗MalfunctionApr 7, 2026No Apparent Adverse Event; Imprecise or Erratic Results
REPORTS ERRATIC RESULTS ON 15 TESTS ACROSS ALL ANALYTES WHEN REUSING A SINGLE-USE DEVICE. UNKNOWN IF PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 11 OF 15.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808953 ↗MalfunctionApr 7, 2026No Apparent Adverse Event; Imprecise or Erratic Results
REPORTS ERRATIC RESULTS ON 15 TESTS ACROSS ALL ANALYTES WHEN REUSING A SINGLE-USE DEVICE. UNKNOWN IF PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 10 OF 15.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808949 ↗MalfunctionApr 7, 2026No Apparent Adverse Event; Imprecise or Erratic Results
REPORTS ERRATIC RESULTS ON 15 TESTS ACROSS ALL ANALYTES WHEN REUSING A SINGLE-USE DEVICE. UNKNOWN IF PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 8 OF 15.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808948 ↗MalfunctionApr 7, 2026No Apparent Adverse Event; Imprecise or Erratic Results
REPORTS ERRATIC RESULTS ON 15 TESTS ACROSS ALL ANALYTES WHEN REUSING A SINGLE-USE DEVICE. UNKNOWN IF PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 4 OF 15.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808947 ↗MalfunctionApr 7, 2026No Apparent Adverse Event; Imprecise or Erratic Results
REPORTS ERRATIC RESULTS ON 15 TESTS ACROSS ALL ANALYTES WHEN REUSING A SINGLE-USE DEVICE. UNKNOWN IF PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 7 OF 15.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808946 ↗MalfunctionApr 7, 2026No Apparent Adverse Event; Imprecise or Erratic Results
REPORTS ERRATIC RESULTS ON 15 TESTS ACROSS ALL ANALYTES WHEN REUSING A SINGLE-USE DEVICE. UNKNOWN IF PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 9 OF 15.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808945 ↗MalfunctionApr 7, 2026No Apparent Adverse Event; Imprecise or Erratic Results
REPORTS ERRATIC RESULTS ON 15 TESTS ACROSS ALL ANALYTES WHEN REUSING A SINGLE-USE DEVICE. UNKNOWN IF PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 6 OF 15.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808944 ↗MalfunctionApr 7, 2026No Apparent Adverse Event; Imprecise or Erratic Results
REPORTS ERRATIC RESULTS ON 15 TESTS ACROSS ALL ANALYTES WHEN REUSING A SINGLE-USE DEVICE. UNKNOWN IF PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 2 OF 15.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808942 ↗MalfunctionApr 7, 2026No Apparent Adverse Event; Imprecise or Erratic Results
REPORTS ERRATIC RESULTS ON 15 TESTS ACROSS ALL ANALYTES WHEN REUSING A SINGLE-USE DEVICE. UNKNOWN IF PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 3 OF 15.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808941 ↗MalfunctionApr 7, 2026No Apparent Adverse Event; Imprecise or Erratic Results
REPORTS ERRATIC RESULTS ON 15 TESTS ACROSS ALL ANALYTES WHEN REUSING A SINGLE-USE DEVICE. UNKNOWN IF PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 5 OF 15.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808940 ↗MalfunctionApr 7, 2026No Apparent Adverse Event; Imprecise or Erratic Results
REPORTS ERRATIC RESULTS ON 15 TESTS ACROSS ALL ANALYTES WHEN REUSING A SINGLE-USE DEVICE. UNKNOWN IF PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 1 OF 15.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808939 ↗
Other COVID-19 Multi-Analyte Antigen Device devices
- CorDx Tyfast ACT21001-25Coretests, Inc. · Covid-19 Multi-Analyte Antigen Device2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.