ID NOW™ COVID-19 190-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,932 adverse event reports that list this exact device (DI 10811877011269), received between May 5, 2020 and Jun 30, 2023 — classified as 4 deaths, 51 injuries, 1,877 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (992 reports).

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 1,932 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FAMILY MEMBER CALLED ABBOTT TECHNICAL SERVICES (TS) TO OBTAIN CLARIFICATION ON A MEDICAL REPORT PROVIDED BY A HOSPITAL WHERE THEIR PARENT HAD BEEN ADMITTED. THE MEDICAL REPORT INDICATED THAT THE PATIENT TESTED POSITIVE FOR COVID-19 USING AN ID NOW COVD-19 ASSAY, WITH A ¿NEGATIVE¿ REFERENCE RANGE. THE FAMILY MEMBER REPORTED THAT THEIR PARENT HAD BEEN ADMITTED TO THE HOSPITAL DUE TO SHORTNESS OF BREATH AND A MILD COUGH ON (B)(6) 2021 AND WAS INFORMED BY THE HOSPITAL THAT THE PATIENT TESTED POSITIVE FOR COVID-19 USING AN ID NOW COVID-19 ASSAY. THE PATIENT UNDERWENT A BATTERY OF TESTS, NONE OF WHICH WERE CONFIRMATORY OR REPEAT COVID-19 TESTS. THE PATIENT WAS REPORTED TO HAVE BEEN IN THE MID STAGES OF RENAL FAILURE AT THE TIME OF ADMITTANCE TO THE HOSPITAL AND PASSED AWAY ON (B)(6) 2021. THE FAMILY MEMBER REPORTED THAT THE DEATH CERTIFICATE INDICATED THAT THE PATIENT EXPIRED DUE TO ACUTE HYPOXEMIC RESPIRATORY FAILURE WITH AN UNDERLYING CAUSE OF COVID-19. SUBSEQUENT TO THE INITIAL SUBMISSION, A MEDWATCH REPORT (B)(4) WAS RECEIVED IN WHICH THE FAMILY MEMBER ALLEGED THE (B)(6) 2021 POSITIVE TEST RESULT WAS FALSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239510 ↗
• MalfunctionJan 18, 2023Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED A CONFLICTING RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2023 ON A NASAL SWAB. THE FIRST TEST GENERATED A POSITIVE RESULT WHILE THE SECOND TEST GENERATED A NEGATIVE RESULT. REPEAT TESTING WAS PERFORMED ON (B)(6) 2023 WITH THE ID NOW COVID-19 ASSAY ON A NASAL SWAB AND GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. THE CUSTOMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16198101 ↗
• MalfunctionDec 29, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS PERFORMED ON VARIOUS DATES WITH TWO (2) DIFFERENT LOT NUMBERS. THIS MFR. REPORT SIX (6) OF SIX (6). THIS REPORT REPRESENTS TWO (2) PATIENTS WITH LOT NUMBER 1021947. IDENTIFYING PATIENT DEMOGRAPHICS WERE NOT PROVIDED. THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 A DIRECT TESTED NASAL KITTED SWAB. THE NASAL SWAB WAS USED TO SWAB BOTH NOSTRILS AND REPEAT TESTING WAS PERFORMED. CONFIRMATION TESTING ON NASAL SWABS WITH PCR GENERATED NEGATIVE RESULTS; CT VALUES NOT PROVIDED. THE CUSTOMER STATED THE PATIENTS WERE PRE-SURGICAL AND WERE BEING TESTED BEFORE SURGERY. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16074892 ↗
• MalfunctionDec 7, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE IDNOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022 USING A DIRECT TESTED KIT SWAB WITH A NASAL SAMPLE. REPEAT TESTING WAS PERFORMED ON ANOTHER ID NOW INSTRUMENT THE SAME DAY AND GENERATED A NEGATIVE RESULT. CONFIRMATION TESTING WAS PERFORMED USING PCR TEST (PLATFORM: UNKNOWN) ON A NASOPHARYNGEAL SAMPLE COLLECTED ON (B)(6) 2022 TESTED DIRECTLY ON NASAL SAMPLE, GENERATED A NEGATIVE RESULT. PER THE CUSTOMER, NO ADDITIONAL INFORMATION WILL BE PROVIDED. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15932627 ↗
• MalfunctionNov 22, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE IDNOW COVID-19 ASSAY PERFORMED (UNKNOWN) ON A NASAL SWAB SAMPLE COLLECTED ON (B)(6)2022. CONFIRMATION TESTING (PLATFORM: DIASORIN) ON A NASOPHARYNGEAL SAMPLE COLLECTED ON (B)(6)2022 IN VIRAL TRANSPORT MEDIA GENERATED A POSITIVE RESULT. PER THE CUSTOMER, NO ADDITIONAL INFORMATION WILL BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15842748 ↗
• MalfunctionNov 14, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 9 FALSE POSITIVE RESULTS WITH ID NOW COVID-19 ON (B)(6) 2022.THE PATIENT RECEIVED A POSITIVE RESULT ON D NOW COVID-19 ON 31OCT2022.NO CONFIRMATORY TEST WAS PERFORMED. THIS MFR. REPORT ADDRESSES TEST EIGHT (8) OF NINE (9) TESTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794750 ↗
• MalfunctionNov 14, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 9 FALSE POSITIVE RESULTS WITH ID NOW COVID-19 ON 31OCT2022.THE PATIENT RECEIVED A POSITIVE RESULT ON ID NOW COVID-19 ON 31OCT2022. THIS MFR. REPORT ADDRESSES TEST NINE (9) OF NINE (9) TESTS. NO CONFIRMATORY TEST WAS PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794709 ↗
• MalfunctionNov 14, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 9 FALSE POSITIVE RESULTS WITH ID NOW COVID-19 ON (B)(6) 2022. THE PATIENT RECEIVED A POSITIVE RESULT ON ID NOW COVID-19 ON (B)(6) 2022. NO CONFIRMATORY TEST WAS PERFORMED. THIS MFR. REPORT ADDRESSES TEST SEVEN (7) OF NINE (9) TESTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789661 ↗
• MalfunctionNov 14, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 9 FALSE POSITIVE RESULTS WITH ID NOW COVID-19 ON (B)(6)2022.THE PATIENT RECEIVED A POSITIVE RESULT ON ID NOW COVID-19 ON 31OCT2022. A CONFIRMATION TESTING WAS PERFORMED (TEST PLATFORM UNKNOWN) AND GENERATED A NEGATIVE RESULT. PER THE CUSTOMER, THE PATIENT HAS BEEN IN 5 DAYS QUARANTINE. THIS MFR. REPORT ADDRESSES TEST SIX (6) OF NINE (9) TESTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789546 ↗
• MalfunctionNov 14, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 9 FALSE POSITIVE RESULTS WITH ID NOW COVID-19 ON (B)(6)2022.THE PATIENT RECEIVED A POSITIVE RESULT ON ID NOW COVID-19 ON (B)(6)2022. NO CONFIRMATORY TEST WAS PERFORMED. THE PATIENT WAS RECOMMENDED TO TAKE TYLENOL AS NEEDED. THIS MFR. REPORT ADDRESSES TEST FIVE (5) OF NINE (9) TESTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789424 ↗
• MalfunctionNov 14, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 9 FALSE POSITIVE RESULTS WITH ID NOW COVID-19 ON (B)(6) 2022. THE PATIENT RECEIVED A POSITIVE RESULT ON ID NOW COVID-19 ON (B)(6) 2022. NO CONFIRMATORY TEST WAS PERFORMED. THIS MFR. REPORT ADDRESSES TEST FOUR (4) OF NINE (9) TESTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789371 ↗
• MalfunctionNov 14, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 9 FALSE POSITIVE RESULTS WITH ID NOW COVID-19 ON (B)(6) 2022.THE PATIENT RECEIVED A POSITIVE RESULT ON ID NOW COVID-19, AND A NEGATIVE RESULT ON UNKNOWN PLATFORM TEST.THE PATIENT WAS RECOMMENDED TO TAKE BICILLIN FOR STREP INFECTION. THIS MFR. REPORT ADDRESSES TEST THREE (3) OF NINE (9) TESTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789186 ↗
• MalfunctionNov 14, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 9 FALSE POSITIVE RESULTS WITH ID NOW COVID-19 ON (B)(6) 2022.THE PATIENT RECEIVED A FALSE POSITIVE RESULT ON ID NOW COVID-19, AND NEGATIVE RESULT ON UNKNOWN PLATFORM TEST. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF NINE (9) TESTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788934 ↗
• MalfunctionNov 14, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 9 FALSE POSITIVE RESULTS WITH ID NOW COVID-19 ON 31OCT2022.THE PATIENT WAS RECOMMENDED TO REST AND TAKE TYLENOL AS NEEDED. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF NINE (9) TESTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788788 ↗
• MalfunctionNov 7, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE IDNOW COVID-19 ASSAY PERFORMED (UNKNOWN) ON A NASAL SWAB SAMPLE COLLECTED ON (B)(6) 2022. CONFIRMATION TESTING (PLATFORM: CORE LAB) ON A NASOPHARYNGEAL SAMPLE COLLECTED ON (B)(6) 2022 IN VIRAL TRANSPORT MEDIA GENERATED A NEGATIVE RESULT. PER THE CUSTOMER, NO ADDITIONAL INFORMATION WILL BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15748890 ↗
• MalfunctionNov 7, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED (UNKNOWN DATE) ON A NASAL SWAB SAMPLE COLLECTED ON (B)(6) 2022. CONFIRMATION TESTING (PLATFORM: (B)(6) LAB) ON A NASOPHARYNGEAL SAMPLE COLLECTED ON (B)(6) 2022 IN VIRAL TRANSPORT MEDIA GENERATED A NEGATIVE RESULT. PER THE CUSTOMER, NO ADDITIONAL INFORMATION WILL BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15748290 ↗
• MalfunctionNov 4, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022 USING A DIRECT TESTED ANTERIOR NASAL SWAB SAMPLE. RETESTING WAS PERFORMED ON THE SAME DAY WITH THE ID NOW COVID-19 ASSAY AND GENERATED A NEGATIVE RESULT. CONFIRMATION PCR TESTING WAS PERFORMED ON (B)(6) 2022 THAT GENERATED A NEGATIVE RESULT ON A NASOPHARYNGEAL SAMPLE. THE PATIENT WAS REPORTEDLY ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15729549 ↗
• MalfunctionNov 3, 2022False Positive Result; False Positive Result

  THE CONSUMER REPORTED MULTIPLE UNCONFIRMED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED FOR UNKNOW NUMBER OF PATIENTS ON (B)(6) 2022. THIS MFR. REPORT ADDRESSES THE TESTS THAT PERFORMED WITH LOT 1085368 AND IS REPORT TWO (2) OF TWO (2). THE CONSUMER REPORTED MULTIPLE FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022 (SAMPLE TYPE UNKNOWN). NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15721068 ↗
• MalfunctionNov 3, 2022False Positive Result; False Positive Result

  THE CONSUMER REPORTED MULTIPLE UNCONFIRMED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED FOR UNKNOW NUMBER OF PATIENTS ON 10OCT2022. THIS MFR. REPORT ADDRESSES THE TESTS THAT PERFORMED WITH LOT 1086710 AND IS REPORT ONE (1) OF TWO (2). THE CONSUMER REPORTED MULTIPLE FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6)2022 (SAMPLE TYPE UNKNOWN). NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15719500 ↗
• MalfunctionOct 24, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022 ON A NASAL SAMPLE. CONFIRMATION TESTING ON NASOPHARYNGEAL SAMPLE WITH (PLATFORM: ABBOTT M2000) GENERATED A NEGATIVE RESULT (CT VALUES NOT PROVIDED). NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15663642 ↗
• MalfunctionOct 20, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022 USING A NASAL SWAB. CONFIRMATION TESTING WAS PERFORMED ON (B)(6) 2022 (PLATFORM: DIASORIN) WAS PERFORMED ON A NASOPHARYNGEAL SWAB IN VIRAL TRANSPORT MEDIA AND GENERATED A POSITIVE RESULT. THE CUSTOMER STATED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15640783 ↗
• MalfunctionOct 17, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022 USING A NASAL SWAB. CONFIRMATION TESTING (PLATFORM: CORE LAB) WAS PERFORMED ON A NASOPHARYNGEAL SWAB IN VIRAL TRANSPORT MEDIA AND GENERATED A NEGATIVE RESULT THE SAME DAY. THE CUSTOMER STATED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615671 ↗
• MalfunctionOct 7, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A UNCONFIRMED FALSE POSITIVE RESULTS WITH ID NOW COVID-19 ASSAY PERFORMED ON UNKNOWN DATE ON AN UNKNOWN NUMBER OF SAMPLES. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15567489 ↗
• MalfunctionOct 3, 2022False Positive Result; Non Reproducible Results; False Positive Result; Non Reproducible Results

  THE CUSTOMER REPORTED SEVEN (7) CONFLICTING RESULTS WITH THE ID NOW COVID-19 ASSAY FOR SEVEN (7) PATIENTS PERFORMED ON VARIOUS DATES. THIS REPORT ADDRESSES PATIENT SIX (6) OF SEVEN (7). THE CUSTOMER REPORTED A CONFLICTING RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON UNKNOWN DATE. INITIAL TEST WAS POSITIVE AND REPEAT TESTING WAS PERFORMED AND GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15528777 ↗
• MalfunctionOct 3, 2022Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED SEVEN (7) CONFLICTING RESULTS WITH THE ID NOW COVID-19 ASSAY FOR SEVEN (7) PATIENTS PERFORMED ON VARIOUS DATES. THIS REPORT ADDRESSES PATIENT TWO (2) OF SEVEN (7). THE CUSTOMER REPORTED A CONFLICTING RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022 ON A DIRECT TESTED NASAL SWAB. REPEAT TESTING WAS PERFORMED AND GENERATED A NEGATIVE RESULT. AS PER CUSTOMER PATIENT WAS NOT SYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15528764 ↗