Sofia 20374Recalls & reported problems
Quidel Corporation · Sofia® SARS Antigen FIA
Quick summary
This Sofia SARS antigen test from Quidel is a diagnostic test kit. Most reports describe incorrect results, mainly false positives (2,660 reports) and also false negatives (844 reports). The 3,695 reports include no deaths and no injuries. No recalls name this device.
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
- 3,695
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,695 adverse event reports that list this exact device (DI 30014613339083), received between Mar 1, 2022 and Jan 9, 2026 — classified as 3,695 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (2,660 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- No Apparent Adverse Event3,695
- False Positive Result2,660
- False Negative Result844
- Imprecise or Erratic Results177
- Incorrect, Inadequate or Imprecise Result or Readings12
Patient problems
- No Clinical Signs, Symptoms or Conditions3,676
- Insufficient Information75
Recent adverse event reports
The 25 most recent of 3,695 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2026False Positive Result; No Apparent Adverse Event
REPORTS SUSPECTED FALSE POSITIVE RESULTS, UNCOMFIRMED WITH ALTERNATE TEST METHOD WITH 2 PATIENTS. UNKNOWN IF PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24030632 ↗MalfunctionJan 9, 2026False Positive Result; No Apparent Adverse Event
REPORTS SUSPECTED FALSE POSITIVE RESULTS, UNCONFIRMED WITH ALTERNATE TEST METHOD WITH 2 PATIENTS. UNKNOWN IF PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24030631 ↗MalfunctionOct 15, 2025False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event
REPORTS FALSE NEGATIVE RESULT OF TWO PATIENT'S SAMPLES, COMFIRMED WITH PCR TEST. UNKNOWN IF PATIENT'S WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23287028 ↗MalfunctionOct 15, 2025False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event
REPORTS FALSE NEGATIVE RESULT O TWO PATIENT SAMPLES, CONFIRMED WITH PCR TEST. UNKNOWN IF PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23285974 ↗MalfunctionJul 30, 2025False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event
REPORTS SUSPECTED FALSE NEGATIVE RESULTS, UNCOMFIRMED WITH ALTERNATE TEST METHOD. UNKNOWN IF PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT. EXCAT NUMBER OF SUSPECTED FALSE POSITVES NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22667158 ↗MalfunctionJun 17, 2025False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event
REPORTS FALSE NEGATIVE RESULT, UNCOMFIRMED WITH ALTERNATE TEST METHOD. PATIENTS WERE SYMPTOMATIC. NO APPARENT ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22238524 ↗MalfunctionOct 11, 2024No Apparent Adverse Event; Imprecise or Erratic Results; No Apparent Adverse Event; Imprecise or Erratic Results
INCONSISTENT SARS RESULTS REPORTED. CUSTOMER RECEIVED ONE POSITIVE AND ONE NEGATIVE RESULT, CUSTOMER DOES NOT ALLOW PROPER EXTRACTION TIME. UNKNOWN IS SYMPTOMATIC OR ASYMPTOMATIC. UNKNOWN IF THE RESULT WAS CONFIRMED. REPORT 2 OF 2.
Patient problems: Insufficient Information
MAUDE report 20434481 ↗MalfunctionOct 11, 2024No Apparent Adverse Event; Imprecise or Erratic Results; No Apparent Adverse Event; Imprecise or Erratic Results
INCONSISTENT SARS RESULTS REPORTED. CUSTOMER RECEIVED ONE POSITIVE AND ONE NEGATIVE RESULT, CUSTOMER DOES NOT ALLOW PROPER EXTRACTION TIME. UNKNOWN IS SYMPTOMATIC OR ASYMPTOMATIC. UNKNOWN IF THE RESULT WAS CONFIRMED. REPORT 1 OF 2.
Patient problems: Insufficient Information
MAUDE report 20434478 ↗MalfunctionOct 2, 2024No Apparent Adverse Event; Imprecise or Erratic Results; No Apparent Adverse Event; Imprecise or Erratic Results
CUSTOMER REPORTED CONFLICTING RESULTS BETWEEN SOFIA ANALYZER AND SOFIA2 INSTRUMENT. CUSTOMER UNABLE TO CONFIRM IF PATIENT OR CONTROL SAMPLE WAS USED IN TESTING, NOR NUMBER OF TESTS PERFORMED. REPORTING TWO MDRS TO ADHERE TO EUA REQUIREMENTS. REPORT 2 OF 2.
Patient problems: Insufficient Information
MAUDE report 20352640 ↗MalfunctionOct 2, 2024False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event
REPORTED ONE FALSE NEGATIVE SARS RESULT FOR ONE PATIENT. THE CUSTOMER COMMUNICATED THE RESULT WAS CONFIRMED BY ANOTHER RAPID ANTIGEN ASSAY.
Patient problems: Insufficient Information
MAUDE report 20352600 ↗MalfunctionOct 2, 2024No Apparent Adverse Event; Imprecise or Erratic Results; No Apparent Adverse Event; Imprecise or Erratic Results
CUSTOMER REPORTED CONFLICTING RESULTS BETWEEN SOFIA ANALYZER AND SOFIA2 INSTRUMENT. CUSTOMER UNABLE TO CONFIRM IF PATIENT OR CONTROL SAMPLE WAS USED IN TESTING, NOR NUMBER OF TESTS PERFORMED. REPORTING TWO MDRS TO ADHERE TO EUA REQUIREMENTS. REPORT 1 OF 2.
Patient problems: Insufficient Information
MAUDE report 20352442 ↗MalfunctionAug 7, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING 1 PATIENTS TESTING POSITIVE FOR SARS. CUSTOMER STATES THE PATIENT IS SYMPTOMATIC AND NO CONFIRMATION TESTING HAS BEEN PERFORMED BUT FEELS THE RESULT IS NOT CORRECT (FALSE POSITIVE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19935492 ↗MalfunctionJul 18, 2023No Apparent Adverse Event; Imprecise or Erratic Results; No Apparent Adverse Event; Imprecise or Erratic Results
REPORTED CONFLICTING SARS RESULTS FOR 1 SYMPTOMATIC PATIENT. THE CUSTOMER COMMUNICATED THAT THE PATIENT FIRST TESTED NEGATIVE AND THEN LATER POSITIVE WHEN RETESTING USING A DIFFERENT SOFIA ANALYZER. NO CONFIRMATORY TESTING HAD BEEN COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17345649 ↗MalfunctionMay 5, 2023False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
REPORTED FALSE POSITIVE SARS RESULTS FOR AN UNKNOWN NUMBER OF PATIENTS. IT IS UNKNOWN IF THE PATIENTS WERE SYMPTOMATIC OR IF CONFIRMATORY TESTING WAS PERFORMED. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER FOR MORE INFORMATION. THE CUSTOMER WAS UNRESPONSIVE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16877964 ↗MalfunctionApr 17, 2023No Apparent Adverse Event; Imprecise or Erratic Results; No Apparent Adverse Event; Imprecise or Erratic Results
REPORTED CONFLICTING SARS RESULTS FOR 1 PATIENT. IT IS UNKNOWN IF THE PATIENT WAS SYMPTOMATIC. THE CUSTOMER COMMUNICATED THAT THE PATIENT FIRST TESTED POSITIVE AND THEN NEGATIVE WITH A RETEST THE SAME DAY. IT WAS COMMUNICATED THAT THE SAME SWAB WAS USED FOR THE RETEST (OFF-LABEL USE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16755867 ↗MalfunctionMar 30, 2023False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
SUSPECTED FALSE POSITIVE SARS RESULT FOR 1 HIGHLY SYMPTOMATIC PATIENT. THE CUSTOMER COMMUNICATED THAT THE PATIENT ALSO TESTED POSITIVE WITH A DIFFERENT SOFIA CASSETTE FOR ANOTHER ANALYTE (FLU A/B AND STREP A+). THE CUSTOMER DID NOT PERFORM CONFIRMATION TESTING BUT DOES NOT SUSPECT THE PATIENT DO BE POSITIVE FOR BOTH. IT WAS REPORTED THAT THIRD PARTY SWABS FROM THE ICU WERE USED FOR SAMPLE COLLECTIONS (OFF-LABEL USE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16651660 ↗MalfunctionMar 30, 2023False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
SUSPECTED FALSE POSITIVE SARS RESULT FOR 1 HIGHLY SYMPTOMATIC PATIENT. THE CUSTOMER COMMUNICATED THAT THE PATIENT ALSO TESTED POSITIVE WITH A DIFFERENT SOFIA CASSETTE FOR ANOTHER ANALYTE (FLU A/B AND STREP A+). THE CUSTOMER DID NOT PERFORM CONFIRMATION TESTING BUT DOES NOT SUSPECT THE PATIENT DO BE POSITIVE FOR BOTH. IT WAS REPORTED THAT THIRD PARTY SWABS FROM THE ICU WERE USED FOR SAMPLE COLLECTIONS (OFF-LABEL USE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16651659 ↗MalfunctionMar 30, 2023False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
SUSPECTED FALSE POSITIVE SARS RESULT FOR 1 HIGHLY SYMPTOMATIC PATIENT. THE CUSTOMER COMMUNICATED THAT THE PATIENT ALSO TESTED POSITIVE WITH A DIFFERENT SOFIA CASSETTE FOR ANOTHER ANALYTE (FLU A/B AND STREP A+). THE CUSTOMER DID NOT PERFORM CONFIRMATION TESTING BUT DOES NOT SUSPECT THE PATIENT DO BE POSITIVE FOR BOTH. IT WAS REPORTED THAT THIRD PARTY SWABS FROM THE ICU WERE USED FOR SAMPLE COLLECTIONS (OFF-LABEL USE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16651658 ↗MalfunctionMar 18, 2023False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event
SUSPECTED FALSE NEGATIVE SARS RESULT FOR 1 PATIENT. IT IS UNKNOWN IF THE PATIENT WAS SYMPOTMATIC. THE CUSTOMER COMMUNICATED THE RESULT WAS CONFIRMED POSITIVE BY AN ALTERNATE TESTING METHOD (METHOD NOT PROVIDED).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16569579 ↗MalfunctionMar 18, 2023False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event
SUSPECTED FALSE NEGATIVE SARS RESULT FOR 1 PATIENT. IT IS UNKNOWN IF THE PATIENT WAS SYMPOTMATIC. THE CUSTOMER COMMUNICATED THE RESULT WAS CONFIRMED POSITIVE BY AN ALTERNATE TESTING METHOD (METHOD NOT PROVIDED).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16569541 ↗MalfunctionMar 18, 2023False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event
SUSPECTED FALSE NEGATIVE SARS RESULT FOR 1 PATIENT. IT IS UNKNOWN IF THE PATIENT WAS SYMPOTMATIC. THE CUSTOMER COMMUNICATED THE RESULT WAS CONFIRMED POSITIVE BY AN ALTERNATE TESTING METHOD (METHOD NOT PROVIDED).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16569536 ↗MalfunctionMar 18, 2023False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event
SUSPECTED FALSE NEGATIVE SARS RESULT FOR 1 PATIENT. IT IS UNKNOWN IF THE PATIENT WAS SYMPOTMATIC. THE CUSTOMER COMMUNICATED THE RESULT WAS CONFIRMED POSITIVE BY AN ALTERNATE TESTING METHOD (METHOD NOT PROVIDED).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16569523 ↗MalfunctionMar 18, 2023False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event
SUSPECTED FALSE NEGATIVE SARS RESULT FOR 1 PATIENT. IT IS UNKNOWN IF THE PATIENT WAS SYMPOTMATIC. THE CUSTOMER COMMUNICATED THE RESULT WAS CONFIRMED POSITIVE BY AN ALTERNATE TESTING METHOD (METHOD NOT PROVIDED).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16569509 ↗MalfunctionMar 3, 2023False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
REPORTED FALSE POSITIVE SARS RESULT FOR 1 PATIENT. IT IS UNKNOWN IF THE PATIENT WAS SYMPTOMATIC. THE CUSTOMER COMMUNICATED THE RESULT WAS CONFIRMED NEGATIVE BY MOLECULAR (PCR TESTING). IT WAS REPORTED THAT THE CUSTOMER HAD BEEN USING REMEL M4-RT UTM AS WELL AS THIRD PARTY SWABS (OFF-LABEL USE) TO RUN THE TESTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16482953 ↗MalfunctionMar 3, 2023False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
REPORTED FALSE POSITIVE SARS RESULT FOR 1 PATIENT. IT IS UNKNOWN IF THE PATIENT WAS SYMPTOMATIC. THE CUSTOMER COMMUNICATED THE RESULT WAS CONFIRMED NEGATIVE BY MOLECULAR (PCR TESTING). IT WAS REPORTED THAT THE CUSTOMER HAD BEEN USING REMEL M4-RT UTM AS WELL AS THIRD PARTY SWABS (OFF-LABEL USE) TO RUN THE TESTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16482952 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.