BinaxNOW RSV 430-122Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10811877011191), received between Jan 31, 2024 and Mar 21, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “False Negative Result” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K032166); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW RSV WAIVED 22T PERFORMED ON (B)(6) 2024 ON A NASOPHARYNGEAL SAMPLE. PER THE CUSTOMER, THE PATIENT WAS SYMPTOMATIC AND THEIR SYMPTOMS WORSENED THE NEXT DAY. THEY WERE HOSPITALIZED ON (B)(6) 2024 DUE TO LOW OXYGEN WHERE CONFIRMATION TESTING WAS PERFORMED VIA AN UNKNOWN METHOD WHICH GENERATED A POSITIVE RESULT. THE PATIENT WAS HOSPITALIZED FOR A TOTAL OF TWO (2) NIGHTS AND RECEIVED SUPPLEMENTAL OXYGEN AND NEBULIZER TREATMENTS. THE PATIENT WAS TREATED WITH A DOSE OF DEXAMETHASONE. THE PATIENT IS REPORTED TO HAVE RECOVERED AND IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18952604 ↗
• InjuryJan 31, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAX NOW RSV TEST ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. PER THE CUSTOMER, PRIOR TO INITIAL TESTING, THE PATIENT WAS "REALLY SICK." FOLLOWING THE FALSE RESULT AND PATIENT'S SUBSEQUENT DEPARTURE, THE PATIENT STOPPED BREATHING AND WAS SENT TO A DIFFERENT HOSPITAL WHERE THE PATIENT TESTED POSITIVE FOR RSV ON AN UNKNOWN PLATFORM. THE PATIENT WAS REPORTED TO BE ON A VENTILATOR AS OF 05JAN2024. ALTHOUGH REQUESTED, NO FURTHER INFORMATION INCLUDING TREATMENT AND OUTCOME WAS PROVIDED. NO ADDITIONAL INFORMATION INCLUDING TREATMENT AND OUTCOME WAS PROVIDED. ATTEMPTS TO OBTAIN THIS INFORMATION ARE ONGOING.

  Patient problems: Respiratory Arrest

  MAUDE report 18615655 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032166. One submission often covers many models, so check the product and lot details in each record.

• Z-0824-2007 · Mar 28, 2007 · Terminated
  BinaxNOW RSV 10 Test Kit Part Number : 430-100, contains NP Swabs with '8995' labeled on the swab wrapper
• Z-0778-04 · Feb 18, 2004 · Terminated
  NOW RSV Test Item Number 430-430, Kit Number 430-00R