ID NOW™ Instrument EQ00200XRecalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00811877010593), received between Aug 24, 2020 and Jan 22, 2025 — classified as 1 injury, 43 malfunctions.

The most frequently reported specific device problem is “Smoking” (18 reports).

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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2025Smoking; Smoking

  THE CUSTOMER REPORTED VISIBLE SMOKE COMING FROM THE ID NOW INSTRUMENT ON 13JAN2025. THE CUSTOMER INDICATED THAT THE INSTRUMENT HAD NOT BEEN POWERED ON IN A LONG TIME AND WAS NOT POWERING ON, THE CUSTOMER REPORTED SEEING SMOKE FROM THE BACK OF THE ID NOW INSTRUMENT AND THAT IT SMELLED LIKE A BURNT WIRE. THERE WAS NO EVIDENCE OF VISIBLE SPARK OR FIRE. THERE WAS NO PATIENT INVOLVED. THE CUSTOMER CONFIRMED THERE WAS NO INJURY OR HARM ASSOCIATED WITH THE SMOKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21209533 ↗
• MalfunctionAug 22, 2024Smoking; Smoking

  THE CUSTOMER REPORTED VISIBLE SMOKE COMING FROM THE ID-NOW INSTRUMENT ON OR BEFORE (B)(6) 2024. THE CUSTOMER REPORTED A POWER OUTAGE HAPPENED IN THEIR AREA AT THE TIME OF THE EVENT. THERE WAS NO VISIBLE SPARK OR FIRE. AFTER SMOKE WAS OBSERVED, THE INSTRUMENT NO LONGER WORKED. THERE WAS NO PATIENT INVOLVED. THE CUSTOMER CONFIRMED THERE WAS NO INJURY OR HARM ASSOCIATED WITH THE SMOKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20039275 ↗
• MalfunctionJun 6, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER REPORTED THAT THE POWER CORD PLUG ON THE ID NOW INSTRUMENT SHORT CIRCUITED AND HAS A BURNT AREA ON OR BEFORE (B)(6)2024. THE CUSTOMER CONFIRMED THERE WAS NO ADVERSE EVENT OR EFFECT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477268 ↗
• MalfunctionFeb 21, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED TWO FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6)2024 AND (B)(6)2024 WITH UNKNOWN SAMPLE TYPES. THIS MANUFACTURER¿S REPORT ADDRESSES TEST TWO (2) OF TWO (2). THE CUSTOMER PERFORMED THE FIRST TEST WITH AN ID NOW COVID-19 2.0 ASSAY ON 16JAN2024 AND GENERATED A POSITIVE. THE SECOND TEST, WITH AN ID NOW COVID-19 2.0 ASSAY, WAS PERFORMED ON THE SAME PATIENT ON 29JAN2024 AND GENERATED A POSITIVE RESULT. PCR CONFIRMATION TESTING WAS PERFORMED ON THE SAME PATIENT ON 26JAN2024 AND GENERATED A NEGATIVE RESULT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754058 ↗
• MalfunctionFeb 21, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED TWO FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6)2024 AND (B)(6)2024 WITH UNKNOWN SAMPLE TYPES. THIS MANUFACTURER¿S REPORT ADDRESSES TEST ONE (1) OF TWO (2). THE CUSTOMER PERFORMED THE FIRST TEST WITH AN ID NOW COVID-19 2.0 ASSAY ON (B)(6)2024 AND GENERATED A POSITIVE. THE SECOND TEST, WITH AN ID NOW COVID-19 2.0 ASSAY, WAS PERFORMED ON THE SAME PATIENT ON (B)(6)2024 AND GENERATED A POSITIVE RESULT. PCR CONFIRMATION TESTING WAS PERFORMED ON THE SAME PATIENT ON (B)(6)2024 AND GENERATED A NEGATIVE RESULT. THE DATE OF THE PATIENT¿S PLASTIC SURGERY WAS POSTPONED. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754055 ↗
• MalfunctionJan 12, 2024Sparking; Sparking

  THE CUSTOMER REPORTED THAT THE ID NOW INSTRUMENT MADE A LOUD NOISE AND HAD A VISIBLE SPARK INSIDE THE REAGENT COMPARTMENT WHILE UPDATING THE INSTRUMENT ON 21DEC2023. THE CUSTOMER REPORTED THAT THE SCREEN WENT OFF, THE INSTRUMENT SHUTDOWN, AND IT FAILS TO START. THE CUSTOMER CONFIRMED THERE WAS NO HARM AS A RESULT OF THE EVENT. DESPITE DUE DILIGENCE ATTEMPTS, NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18504792 ↗
• MalfunctionDec 12, 2023Unintended Electrical Shock; Unintended Electrical Shock

  THE CUSTOMER REPORTED THAT DURING A STORM, THEY EXPERIENCED AN ELECTRIC SHOCK AND A FROZEN SCREEN WITH THE ID NOW INSTRUMENT ON 16NOV2023. THE CUSTOMER STATED THE SHOCK OCCURRED WHEN THEY TOUCHED THE SCREEN OF THE DEVICE WHILE IT WAS CONNECTED TO A WALL OUTLET. THE INSTRUMENT WAS REBOOTED, AND A DIFFERENT OUTLET WAS TRIED TO NO AVAIL. AS A RESULT, THE INSTRUMENT WAS REPLACED. THE CUSTOMER CONFIRMED THERE WAS NO HARM AS A RESULT OF THE SHOCK. DESPITE DUE DILIGENCE, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Electric Shock

  MAUDE report 18313934 ↗
• MalfunctionJul 25, 2023Sparking; Sparking

  THE CUSTOMER REPORTED A SPARK WITH ID NOW INSTRUMENT WHEN PLUGGED DIRECTLY INTO A POWER OUTLET. THE CUSTOMER STATED THEY INITIALLY PLUGGED IN ID NOW INSTRUMENT DIRECTLY TO THE WALL OUTLET AND INSTRUMENT SCREEN WAS FROZEN. THE CUSTOMER THEN UNPLUGGED THE INSTRUMENT AND PLUGGED IT IN DIFFERENT WALL OUTLET UPON WHICH THE CUSTOMER REPORTED A SPARK. THE CUSTOMER DID NOT INDICATE WHERE THE SPARK ORIGINATED FROM. THE CUSTOMER STATED THAT THERE WAS NO IMMEDIATE DANGER AND THERE WAS NO INJURY. THERE WAS NO PATIENT INVOLVEMENT, AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390765 ↗
• MalfunctionJun 14, 2023Fire; Smoking; Sparking; Fire; Smoking; Sparking

  THE CUSTOMER REPORTED THAT THE ID NOW INSTRUMENT SPARKED WHEN PLUGGED DIRECTLY INTO A WALL OUTLET DURING ROUTINE INSPECTION. THE INSTRUMENT WAS THEN POWERED ON AND SMOKE WAS OBSERVED BY THE CUSTOMER. A SHORT TIME AFTER THE INSTRUMENT WAS POWERED ON, THE CUSTOMER REPORTED SEEING A SMALL FIRE ON THE UNIT. THE CUSTOMER STATED NO ONE WAS INJURED AND THE DEVICE WAS POWERED OFF AND WILL NOT BE POWERED ON. THERE WAS NO PATIENT INVOLVEMENT, AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17130589 ↗
• MalfunctionMay 31, 2023Smoking; Smoking

  THE CUSTOMER REPORTED THAT THERE WAS SMOKE COMING FROM THE USB PORT ON THE RIGHT SIDE OF THE ID NOW INSTRUMENT AND THE POWER WENT OUT WITH A "SNAPPING SOUND". CUSTOMER REPORTED THAT THE INSTRUMENT WAS TURNED ON IN THE MORNING, AND WHEN THE CUSTOMER WENT TO USE THE INSTRUMENT IT STARTED TO SMOKE. THERE WAS NO PATIENT INVOLVEMENT AND THE CUSTOMER CONFIRMED THERE WAS NO INJURY OR HARM ASSOCIATED WITH THE SMOKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17030023 ↗
• MalfunctionMay 17, 2023Sparking; Sparking

  THE CUSTOMER REPORTED FRAYED CORD AT CONNECTION POINT WITH ID NOW INSTRUMENT WHICH SPARKED WHEN PLUGGED IN. THE CUSTOMER STATED THAT THERE WAS NO IMMEDIATE DANGER AND THERE WAS NO INJURY. THERE WAS NO PATIENT INVOLVEMENT, AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16948531 ↗
• MalfunctionApr 20, 2023Sparking; Sparking

  THE CUSTOMER REPORTED A SPARK WHEN PLUGGING THE UNIVERSAL PRINTER POWER CABLE INTO THE WALL OUTLET WHILE THE PRINTER WAS CONNECTED TO THE IDNOW INSTRUMENT. THE CUSTOMER STATED THE ISSUE DOES NOT OCCUR WHEN A DIFFERENT POWER CABLE IS USED, AND THEY BELIEVE THAT THE CABLE IS THE ISSUE AND NOT THE PRINTER OR INSTRUMENT. THE CUSTOMER CONFIRMED THERE WAS NO EVIDENCE OF SMOKE, FIRE, BURNING, OR SHOCK, AND STATED THE SPARK WAS "MILD". THERE WAS NO PATIENT INVOLVEMENT, AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781673 ↗
• MalfunctionMar 30, 2023Device Emits Odor; Smoking; Device Emits Odor; Smoking

  THE CUSTOMER REPORTED THAT THE ID NOW COVID-19 INSTRUMENT HAD SMOKE COMING OUT OF IT AND THERE IS A LINGERING BURNED SMELL. THE ID NOW COVID-19 INSTRUMENT WAS IN A POWER CYCLE AND WILL NO LONGER TURN ON. THERE WAS NO HARM DUE TO THE ISSUE THAT CAUSED THE SMOKE AND BURNED SMELL, OR FROM THE SMOKE AND BURNED SMELL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645169 ↗
• MalfunctionMar 23, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED AN UNKNOWN NUMBER OF FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY TEST PERFORMED ON AN UNKNOWN DATE. CONFIRMATION PCR TESTING (UNKNOWN PLATFORM) WAS PERFORMED AND GENERATED POSITIVE RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16597761 ↗
• MalfunctionMar 2, 2023Sparking; Sparking

  THE CUSTOMER REPORTED THAT THE SCREEN OF THE ID NOW INSTRUMENT SPARKED SUDDENLY ON 17FEB2023. THE CUSTOMER INDICATED THAT THERE ARE NO VISIBLE BURN MARKS, AND NO SMOKE WAS SEEN AS A RESULT OF THE SPARK. THE CUSTOMER CONFIRMED THAT THIS WAS NOT AN OCCURRENCE OF STATIC SHOCK. NO INJURIES OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16472226 ↗
• MalfunctionDec 22, 2022Smoking; Smoking

  THE CUSTOMER REPORTED VISIBLE SMOKE COMING FROM THE ID-NOW INSTRUMENT WHEN THE TEST BASE HOLDER OVERHEATED AND MELTED. THERE WAS NO VISIBLE SPARK OR FIRE. THERE WAS NO PATIENT INVOLVED. THE CUSTOMER CONFIRMED THERE WAS NO INJURY OR HARM ASSOCIATED WITH THE SMOKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16034732 ↗
• MalfunctionDec 12, 2022Smoking; Smoking

  THE CUSTOMER REPORTED ON SMOKING INSTRUMENT WITH ID NOW COVID-19 INSTRUMENT ON (B)(6) 2022.THE CUSTOMER CONFIRMED THERE WAS NO HARM OR INJURY DUE TO THE SMOKING INSTRUMENT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959678 ↗
• MalfunctionNov 4, 2022Smoking; Smoking

  THE CUSTOMER REPORTED SMOKE COMING FROM THE ID NOW INSTRUMENT. PER THE CUSTOMER, THE INSTRUMENT WAS SMOKING AFTER IT WAS TURNED ON AND DID NOT OCCUR DURING USE. THERE WAS NO VISIBLE SPARK OR FIRE. THERE WAS NO PATIENT INVOLVEMENT AND THE CUSTOMER CONFIRMED THERE WAS NO INJURY OR HARM ASSOCIATED WITH THE SMOKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15724580 ↗
• MalfunctionJul 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED AN ISSUE WITH THE ID NOW INSTRUMENT AND THE RESULTS THAT ARE BEING PRINTED FOR TWO PATIENTS. THIS MFR. REPORT ADDRESSES PATIENT TWO (2) OF TWO (2). AS PER THE CUSTOMER TESTING WAS PERFORMED ON ID NOW INSTRUMENT ON A UNKNOWN DATE, GENERATED A NEGATIVE RESULT ON THE INSTRUMENT AND PRINTED A POSITIVE RESULT WHICH WERE NOT THE SAME. CUSTOMER CONFIRMED THE ID'S MATCHED THE PATIENT ON THE INSTRUMENT AND THE PRINTED RESULTS. REPEAT TESTING WAS NOT PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15021974 ↗
• MalfunctionJul 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED AN ISSUE WITH THE ID NOW INSTRUMENT AND THE RESULTS THAT ARE BEING PRINTED FOR TWO PATIENTS. THIS MFR. REPORT ADDRESSES PATIENT ONE (1) OF TWO (2). AS PER THE CUSTOMER TESTING WAS PERFORMED ON ID NOW INSTRUMENT ON A UNKNOWN DATE, GENERATED A POSITIVE RESULT ON THE INSTRUMENT AND PRINTED A NEGATIVE RESULT WHICH WERE NOT THE SAME. CUSTOMER CONFIRMED THE ID'S MATCHED THE PATIENT ON THE INSTRUMENT AND THE PRINTED RESULTS. REPEAT TESTING WAS NOT PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15021799 ↗
• MalfunctionJun 23, 2022Smoking; Smoking

  THE CUSTOMER REPORTED THE ID NOW COVID-19 INSTRUMENT TO BE SMOKING AFTER A HARD REBOOT. THERE WAS NO VISIBLE FIRE OR ANY HARM DUE TO THE SMOKE. THE ID NOW COVID-19 INSTRUMENT WOULD NO LONGER POWER ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14787162 ↗
• MalfunctionJun 20, 2022Smoking; Smoking

  THE CUSTOMER REPORTED THE ID NOW COVID-19 INSTRUMENT TO BE SMOKING WHEN THE INSTRUMENT WAS FIRST TURNED ON. THE ID NOW COVID-19 INSTRUMENT WAS TAKEN OUT OF SERVICE. THE CUSTOMER CONFIRMED THERE WAS NO HARM OR INJURY DUE TO THE SMOKING INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14745863 ↗
• MalfunctionJan 15, 2022Smoking; Smoking

  THE CUSTOMER REPORTED EXPERIENCING SMOKE COMING FROM THE ID NOW INSTRUMENT. AS A RESULT, THE INSTRUMENT WAS UNPLUGGED. THE CUSTOMER CONFIRMED THAT NO ONE WAS INVOLVED OR INJURED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13262560 ↗
• MalfunctionJan 13, 2022Smoking; Smoking

  THE CUSTOMER REPORTED THE ID NOW COVID-19 INSTRUMENT TO BE SMOKING. THE ID NOW COVID-19 INSTRUMENT WAS TAKEN OUT OF SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13253156 ↗
• MalfunctionJan 3, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021. THE CUSTOMER PERFORMED THREE ID NOW COVID-19 ASSAY ON THE PATIENT ON (B)(6) 2021, THE FIRST TWO YIELDED AN INVALID AND THE THIRD A POSITIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142172 ↗

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