Alere™ i Instrument EQ00200XRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00811877010821), received between Jan 15, 2020 and Oct 22, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Smoking” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2021Patient Data Problem; Patient Data Problem

  CUSTOMER ((B)(6)) REPORTED AN ISSUE WITH THE ID NOW INSTRUMENT BARCODE READER (PN EQ001001, MANUFACTURED BY OPTICON). THE CUSTOMER STATED AFTER SCANNING THE PATIENT ID, THE NUMBERS WERE SWAPPED. THE SWAPPED NUMBERS ALIGNED TO A DIFFERENT PATIENT. THE OPERATOR DID NOT CONFIRM PATIENT ID WAS CORRECT BEFORE ENTERING THE NEGATIVE RESULT ON A PATIENT THAT HAD ORDERS, BUT HAD YET TO BE TESTED. THIS ERROR RESULTED IN A NEGATIVE ID NOW COVID-19 RESULT BEING REPORTED ON AN INCORRECT PATIENT. ADDITIONAL INFORMATION, INCLUDE PATIENT TREATMENT, IMPACT AND OUTCOME WERE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12683571 ↗
• InjuryDec 12, 2020Unable to Obtain Readings; Unable to Obtain Readings

  THE CUSTOMER REPORTED THAT A PATIENT'S SURGERY WAS DELAYED AS A RESULT OF A ID NOW COVID-19 TEST (LOT # 1006656) CANCELING WHEN CLOSING THE LID OF AN ID NOW INSTRUMENT ON 18NOV2020. THE CUSTOMER REPORTED THAT TWO ID NOW INSTRUMENTS WERE USED THAT DAY FOR THE PATIENT'S TEST AND BOTH EXPERIENCED TEST CANCELLATION UPON CLOSING THE LID. BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN WHICH INSTRUMENT WAS BEING USED WHEN THE CANCELLATION RESULTED IN THE DELAYED SURGERY. THEREFORE BOTH ARE BEING REPORTED. THIS REPORT REPRESENTS DEVICE ONE (1) OF TWO (2). ALTHOUGH REQUESTED, ADDITIONAL PATIENT INFORMATION, INCLUDING TYPE OF SURGERY, LENGTH OF DELAY, REPEAT OR CONFIRMATION TESTING, TREATMENT AND OUTCOME, WAS NOT PROVIDED. THE CUSTOMER CONFIRMED THAT NO DEATH OCCURRED AS A RESULT OF THIS EVENT.ALTHOUGH THE COMPLAINT WAS FOR THE ID NOW INSTRUMENT, THE EVENT OCCURRED WHEN RUNNING THE ID NOW COVID-19 ASSAY. PER THE ID NOW COVID-19 PRODUCT INSERT (IN190000 REV. 6.0): NOTE: THE TEST WILL BE CANCELLED IF THE LID IS OPENED. IF THE INSTRUMENT DOES NOT DETECT THAT THE LID HAS BEEN CLOSED BY THEN, IT WILL TIME OUT AND ALL TEST PIECES (SAMPLE RECEIVER, TEST BASE, AND TRANSFER CARTRIDGE) MUST BE R

  Patient problems: Insufficient Information

  MAUDE report 10996932 ↗
• InjuryDec 12, 2020Unable to Obtain Readings; Unable to Obtain Readings

  THE CUSTOMER REPORTED THAT A PATIENT'S SURGERY WAS DELAYED AS A RESULT OF A ID NOW COVID-19 TEST (LOT # 1006656) CANCELING WHEN CLOSING THE LID OF AN ID NOW INSTRUMENT ON (B)(6) 2020. THE CUSTOMER REPORTED THAT TWO ID NOW INSTRUMENTS WERE USED THAT DAY FOR THE PATIENT'S TEST AND BOTH EXPERIENCED TEST CANCELLATION UPON CLOSING THE LID. BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN WHICH INSTRUMENT WAS BEING USED WHEN THE CANCELLATION RESULTED IN THE DELAYED SURGERY. THEREFORE BOTH ARE BEING REPORTED. THIS REPORT REPRESENTS DEVICE TWO (2) OF TWO (2). ALTHOUGH REQUESTED, ADDITIONAL PATIENT INFORMATION, INCLUDING TYPE OF SURGERY, LENGTH OF DELAY, REPEAT OR CONFIRMATION TESTING, TREATMENT AND OUTCOME, WAS NOT PROVIDED. THE CUSTOMER CONFIRMED THAT NO DEATH OCCURRED AS A RESULT OF THIS EVENT. ALTHOUGH THE COMPLAINT WAS FOR THE ID NOW INSTRUMENT, THE EVENT OCCURRED WHEN RUNNING THE ID NOW COVID-19 ASSAY. PER THE ID NOW COVID-19 PRODUCT INSERT (IN190000 REV. 6.0): NOTE: THE TEST WILL BE CANCELLED IF THE LID IS OPENED. IF THE INSTRUMENT DOES NOT DETECT THAT THE LID HAS BEEN CLOSED BY THEN, IT WILL TIME OUT AND ALL TEST PIECES (SAMPLE RECEIVER, TEST BASE, AND TRANSFER CARTRIDGE) MUST BE RE

  Patient problems: Insufficient Information

  MAUDE report 10996931 ↗
• MalfunctionJun 5, 2020Smoking; Temperature Problem; Smoking; Temperature Problem

  THERE IS NO ADDITIONAL EVENT OR PROBLEM DESCRIPTION FOR THIS SUPPLEMENTAL REPORT. THE SUPPLEMENTAL INFORMATION IS EXCLUSIVE TO THE INVESTIGATION AND IS DESCRIBED IN H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10126264 ↗
• MalfunctionJan 15, 2020No Display/Image; Electrical /Electronic Property Problem; Failure to Power Up; Smoking; No Display/Image; Electrical /Electronic Property Problem; Failure to Power Up; Smoking

  A CUSTOMER REPORTED A POWER ISSUE AND VISIBLE SMOKE WITH THE ID NOW INSTRUMENT. THE CUSTOMER RECEIVED THE ID NOW INSTRUMENT ON FRIDAY, (B)(6) 2019 AND SET IT UP THE SAME DAY, WITH NO REPORT OF USING THE INSTRUMENT TO RUN ANY SAMPLES. THE CUSTOMER RETURNED TO WORK ON MONDAY, (B)(6) 2019. THE CUSTOMER TRIED TO POWER ON THE ID NOW INSTRUMENT BUT IT WOULD NOT TURN ON, AND THE CUSTOMER OBSERVED SMOKE FROM THE USB PORT. THE INSTRUMENT WAS UNPLUGGED FROM THE POWER SOURCE. NO OTHER INSTRUMENTS WERE PLUGGED INTO THE SAME POWER SOURCE AT THE TIME OF THE EVENT. THE CUSTOMER STATED THERE WAS NOT A POWER OUTAGE OVER THE WEEKEND, ALTHOUGH THE CUSTOMER NOTED THE OFFICE LIGHT WAS ON WHEN THEY LEFT ON FRIDAY AND WAS OFF WHEN THEY RETURNED TO THE OFFICE ON MONDAY. THE EVENT DID NOT CAUSE INJURY OR DEATH. NO ID NOW ASSAY PLATFORMS WERE INVOLVED IN THE EVENT, THEREFORE THERE WAS NO IMPACT TO PATIENT TESTING. THE CUSTOMER RETURNED THE ID NOW INSTRUMENT TO ABBOTT DIAGNOSTICS SCARBOROUGH, INC. FOR INVESTIGATION. VISIBLE SMOKE IS REPORTED AS A MALFUNCTION AS THERE IS POTENTIAL FOR SERIOUS INJURY IF THE EVENT WERE TO RECUR.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9591127 ↗

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