SofiaRecalls & reported problems across all models
Quidel Corporation · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Sofia model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6,983
- Deaths reported
- 1
- Injuries reported
- 4
- Recalls
- 2
We found 5 models of Sofia by Quidel Corporation in the FDA's device registry (GUDID). Together they are named in 6,983 adverse event reports in the FDA's MAUDE database, received between Feb 28, 2018 and Sep 15, 2026 — classified as 1 death, 4 injuries, 6,978 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (5,367 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Sofia recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
Most reported Sofia problems
Device problems
- No Apparent Adverse Event6,979
- False Positive Result5,367
- False Negative Result1,238
- Imprecise or Erratic Results349
- Incorrect, Inadequate or Imprecise Result or Readings18
- Non Reproducible Results6
- Device Handling Problem2
- Chemical Spillage1
Patient problems
- No Clinical Signs, Symptoms or Conditions6,931
- Insufficient Information276
- Respiratory Tract Infection2
- Needle Stick/Puncture1
- Red Eye(s)1
Sofia models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 3,695 reports
- Sofia 20377COVID-19 Multi-Analyte Antigen Device1 recall3,284 reports
- Sofia 20274ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.1 recall2 reports
- Sofia 20218ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C1 death1 report
- Sofia 20260ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS1 report
Recent Sofia adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionAug 25, 2026Material Rupture
Patient problems: Needle Stick/Puncture
MAUDE report 50438178 ↗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 ↗
Other Quidel Corporation products
All Quidel Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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