Alere™ i Influenza A & B 425-024Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10811877010804), received between Feb 1, 2018 and Feb 1, 2018 — classified as 1 death.

The most frequently reported specific device problem is “False Negative Result” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K141520); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathFeb 1, 2018False Negative Result; False Negative Result

  ON (B)(6) 2018, A CUSTOMER IN THE (B)(6) REPORTED TO ALERE (B)(4) THAT A (B)(6) YEAR OLD FEMALE PATIENT PRESENTED ON (B)(6) 2017 TO THE HOSPITAL (B)(4) WITH TYPICAL COLD SYMPTOMS - SHORTNESS OF BREATH, SORE THROAT AND ANXIETY - AND WAS ADMITTED AT 10:30 WITH SUBSEQUENT TRANSFER TO RESUS AT 11:30. THE ALERE I INFLUENZA A&B TEST WAS RUN AT 16:13 USING A DIRECT NASAL SWAB WITH A NEGATIVE RESULT. CUSTOMER CONFIRMED THE WRONG SWAB WAS USED TO RUN THE ALERE I INFLUENZA A&B TEST AND SUSPECTS THERE WAS NOT A LOT OF SAMPLE. THE PATIENT'S CONDITION WORSENED AND WAS TRANSFERRED TO ITU AT 18:30. IN ITU, ADDITIONAL THROAT AND NOSE SAMPLES WERE COLLECTED, POOLED AND SENT OFF THE (B)(6) LABORATORY FOR FURTHER TESTING. THE PATIENT EXPIRED ON (B)(6) 2017 AT 22:05 PRIOR TO AVAILABILITY OF INFLUENZA POSITIVE RT-PCR CONFIRMATORY LAB RESULTS ON (B)(6) 2017. CAUSE OF DEATH REPORTED BY THE CUSTOMER WAS NEUTROPENIC SEPSIS AND THINKS DEATH WAS A DIRECT CONSEQUENCE OF HAVING INFLUENZA; HOWEVER, CUSTOMER DOES NOT HAVE POST MORTEM RESULTS AVAILABLE AT THIS TIME.

  Patient problems: Death; Misdiagnosis

  MAUDE report 7234064 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141520. One submission often covers many models, so check the product and lot details in each record.

• Z-1231-2017 · Jan 25, 2017 · Terminated
  Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package contains 25 transport tubes). The Influenza Swabs in dry transport tubes are intended
• Z-2095-2015 · Jun 26, 2015 · Terminated
  Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagno
• Z-1677-2015 · Apr 22, 2015 · Terminated
  Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isother