ID NOW COVID-19 2.0 192-000Recalls & reported problems
Alere Scarborough, Inc. · A rapid, automated, molecular test for the qualitative detection of COVID-19 viral nucleic acid in anterior nasal swab and nasopharyngeal swab specimens. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This ID NOW COVID-19 2.0 test is a rapid, automated molecular test for the virus that causes COVID-19. Its 143 reports mostly describe wrong results, including 101 false positives and 34 false negatives. There are no deaths and 1 injury. No recalls name this device. Reports fell to 1 in the last 12 months from 8 before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 147
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 00811877011354), received between Nov 1, 2022 and Sep 29, 2026 — classified as 1 injury, 146 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (102 reports).
2 other recalls cover devices cleared under the same FDA submission (K221925); 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.
Reports received per month
Most reported problems
Device problems
- False Positive Result102
- False Negative Result34
- Non Reproducible Results7
- Unable to Obtain Readings2
- Incorrect Measurement1
- Incorrect, Inadequate or Imprecise Result or Readings1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions141
- Insufficient Information6
Recent adverse event reports
The 25 most recent of 147 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937602 ↗MalfunctionJul 19, 2026Non Reproducible Results
THE CUSTOMER REPORTED THREE (3) CONFLICTING RESULTS WITH THE ID NOW COVID-19 ASSAY 2.0 PERFORMED ON THREE (3) SEPARATE PATIENTS ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES PATIENT THREE (3) OF THREE (3). INITIAL TESTING WAS PERFORMED WITH THE ID NOW COVID-19 ASSAY 2.0 USING AN UNKNOWN SAMPLE TYPE WHICH GENERATED A POSITIVE RESULT ON (b)(6) 2026. REPEAT TESTING WAS PERFORMED ON THE SAME DAY, GENERATING A NEGATIVE RESULT. ADDITIONAL TESTING WAS NOT PERFORMED. THE CUSTOMER CONFIRMED THERE WAS NO NEGATIVE IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25867871 ↗MalfunctionJul 19, 2026Non Reproducible Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25867870 ↗MalfunctionJul 19, 2026Non Reproducible Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25867869 ↗MalfunctionJan 28, 2026False Positive Result
THE CUSTOMER REPORTED AN UNKNOWN NUMBER OF FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY TAKEN ON UNKNOWN DATES WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO PATIENT INFORMATION, INCLUDING IMPACT OR OUTCOME, WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24199996 ↗MalfunctionSep 17, 2025False Negative Result; False Negative Result
THE CUSTOMER REPORTED THREE (3) FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON AN UNKNOWN DATE USING DIRECT TESTED THROAT AND NASOPHARYNGEAL SAMPLES. THIS IS REPORT THREE (3) OF THREE (3). THE PATIENT INITIALLY TESTED NEGATIVE WITH THE ID NOW COVID-19 ASSAY. REPEAT TESTING WAS PERFORMED ON TWO (2) DIFFERENT ID NOW INSTRUMENTS, WHICH GENERATED NEGATIVE RESULTS. CONFIRMATION PCR TESTING WAS PERFORMED ON (B)(6) 2025 WITH A NASAL SWAB SAMPLE THAT GENERATED A POSITIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23073886 ↗MalfunctionSep 17, 2025False Negative Result; False Negative Result
THE CUSTOMER REPORTED THREE (3) FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON AN UNKNOWN DATE USING DIRECT TESTED THROAT AND NASOPHARYNGEAL SAMPLES. THIS IS REPORT ONE (1) OF THREE (3). THE PATIENT INITIALLY TESTED NEGATIVE WITH THE ID NOW COVID-19 ASSAY. REPEAT TESTING WAS PERFORMED ON TWO (2) DIFFERENT ID NOW INSTRUMENTS, WHICH GENERATED NEGATIVE RESULTS. CONFIRMATION PCR TESTING WAS PERFORMED ON (B)(6) 2025 WITH A NASAL SWAB SAMPLE THAT GENERATED A POSITIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23073822 ↗MalfunctionSep 17, 2025False Negative Result; False Negative Result
THE CUSTOMER REPORTED THREE (3) FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON AN UNKNOWN DATE USING DIRECT TESTED THROAT AND NASOPHARYNGEAL SAMPLES. THIS IS REPORT TWO (2) OF THREE (3). THE PATIENT INITIALLY TESTED NEGATIVE WITH THE ID NOW COVID-19 ASSAY. REPEAT TESTING WAS PERFORMED ON TWO (2) DIFFERENT ID NOW INSTRUMENTS, WHICH GENERATED NEGATIVE RESULTS. CONFIRMATION PCR TESTING WAS PERFORMED ON (B)(6) 2025 WITH A NASAL SWAB SAMPLE THAT GENERATED A POSITIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23073819 ↗MalfunctionSep 12, 2025False Negative Result; False Negative Result
THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY FOR THREE (3) TO FIVE (5) PATIENTS, PERFORMED ON (B)(6) 2025. THE CUSTOMER INDICATED THAT THE PATIENTS WERE ¿OLDER¿. THIS MFR. REPORT ADDRESSES PATIENT THREE (3) OF FIVE (5). INITIAL TESTING WAS PERFORMED WITH HEALTH RAPID SELF-TEST COVID-19 FLU A&B 3-IN-1 TESTS AND PRODUCED POSITIVE RESULTS. CONFIRMATION TESTING WITH THE ID NOW COVID-19 2.0 ASSAY WAS PERFORMED THE SAME DAY AS THE RAPID SELF-TEST WITH NASAL SWABS AND GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED THE PATIENTS WERE SYMPTOMATIC AT THE TIME OF TESTING AND THAT NO REPEAT OR ADDITIONAL TESTING WAS PERFORMED. THE CUSTOMER INDICATED THAT THAT THE PATIENTS WERE NOT PRESCRIBED PAXLOVID AND THAT THEIR SYMPTOMS WORSENED (FEVER, BODY ACHES, CHILLS, COUGH, SORE THROAT, HEADACHES, RUNNY NOSE, NASAL CONGESTION). THE CUSTOMER DID NOT REPORT IF ANY TREATMENT OR MEDICAL INTERVENTION WAS REQUIRED. THE CURRENT HEALTH STATUS OF THE PATIENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS OBTAINED.
Patient problems: Insufficient Information
MAUDE report 23039346 ↗MalfunctionSep 12, 2025False Negative Result; False Negative Result
THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY FOR THREE (3) TO FIVE (5) PATIENTS, PERFORMED ON (B)(6) 2025. THE CUSTOMER INDICATED THAT THE PATIENTS WERE ¿OLDER¿. THIS MFR. REPORT ADDRESSES PATIENT FIVE (5) OF FIVE (5). INITIAL TESTING WAS PERFORMED WITH HEALTH RAPID SELF-TEST COVID-19 FLU A&B 3-IN-1 TESTS AND PRODUCED POSITIVE RESULTS. CONFIRMATION TESTING WITH THE ID NOW COVID-19 2.0 ASSAY WAS PERFORMED THE SAME DAY AS THE RAPID SELF-TEST WITH NASAL SWABS AND GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED THE PATIENTS WERE SYMPTOMATIC AT THE TIME OF TESTING AND THAT NO REPEAT OR ADDITIONAL TESTING WAS PERFORMED. THE CUSTOMER INDICATED THAT THAT THE PATIENTS WERE NOT PRESCRIBED PAXLOVID AND THAT THEIR SYMPTOMS WORSENED (FEVER, BODY ACHES, CHILLS, COUGH, SORE THROAT, HEADACHES, RUNNY NOSE, NASAL CONGESTION). THE CUSTOMER DID NOT REPORT IF ANY TREATMENT OR MEDICAL INTERVENTION WAS REQUIRED. THE CURRENT HEALTH STATUS OF THE PATIENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS OBTAINED.
Patient problems: Insufficient Information
MAUDE report 23039049 ↗MalfunctionSep 12, 2025False Negative Result; False Negative Result
THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY FOR THREE (3) TO FIVE (5) PATIENTS, PERFORMED ON (B)(6) 2025. THE CUSTOMER INDICATED THAT THE PATIENTS WERE ¿OLDER¿. THIS MFR. REPORT ADDRESSES PATIENT TWO (2) OF FIVE (5). INITIAL TESTING WAS PERFORMED WITH HEALTH RAPID SELF-TEST COVID-19 FLU A&B 3-IN-1 TESTS AND PRODUCED POSITIVE RESULTS. CONFIRMATION TESTING WITH THE ID NOW COVID-19 2.0 ASSAY WAS PERFORMED THE SAME DAY AS THE RAPID SELF-TEST WITH NASAL SWABS AND GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED THE PATIENTS WERE SYMPTOMATIC AT THE TIME OF TESTING AND THAT NO REPEAT OR ADDITIONAL TESTING WAS PERFORMED. THE CUSTOMER INDICATED THAT THAT THE PATIENTS WERE NOT PRESCRIBED PAXLOVID AND THAT THEIR SYMPTOMS WORSENED (FEVER, BODY ACHES, CHILLS, COUGH, SORE THROAT, HEADACHES, RUNNY NOSE, NASAL CONGESTION). THE CUSTOMER DID NOT REPORT IF ANY TREATMENT OR MEDICAL INTERVENTION WAS REQUIRED. THE CURRENT HEALTH STATUS OF THE PATIENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS OBTAINED.
Patient problems: Insufficient Information
MAUDE report 23039048 ↗MalfunctionSep 12, 2025False Negative Result; False Negative Result
THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY FOR THREE (3) TO FIVE (5) PATIENTS, PERFORMED ON (B)(6) 2025. THE CUSTOMER INDICATED THAT THE PATIENTS WERE ¿OLDER¿. THIS MFR. REPORT ADDRESSES PATIENT FOUR (4) OF FIVE (5). INITIAL TESTING WAS PERFORMED WITH HEALTH RAPID SELF-TEST COVID-19 FLU A&B 3-IN-1 TESTS AND PRODUCED POSITIVE RESULTS. CONFIRMATION TESTING WITH THE ID NOW COVID-19 2.0 ASSAY WAS PERFORMED THE SAME DAY AS THE RAPID SELF-TEST WITH NASAL SWABS AND GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED THE PATIENTS WERE SYMPTOMATIC AT THE TIME OF TESTING AND THAT NO REPEAT OR ADDITIONAL TESTING WAS PERFORMED. THE CUSTOMER INDICATED THAT THAT THE PATIENTS WERE NOT PRESCRIBED PAXLOVID AND THAT THEIR SYMPTOMS WORSENED (FEVER, BODY ACHES, CHILLS, COUGH, SORE THROAT, HEADACHES, RUNNY NOSE, NASAL CONGESTION). THE CUSTOMER DID NOT REPORT IF ANY TREATMENT OR MEDICAL INTERVENTION WAS REQUIRED. THE CURRENT HEALTH STATUS OF THE PATIENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS OBTAINED.
Patient problems: Insufficient Information
MAUDE report 23039047 ↗MalfunctionSep 12, 2025False Negative Result; False Negative Result
THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY FOR THREE (3) TO FIVE (5) PATIENTS, PERFORMED ON (B)(6) 2025. THE CUSTOMER INDICATED THAT THE PATIENTS WERE ¿OLDER¿. THIS MFR. REPORT ADDRESSES PATIENT ONE (1) OF FIVE (5). INITIAL TESTING WAS PERFORMED WITH HEALTH RAPID SELF-TEST COVID-19 FLU A&B 3-IN-1 TESTS AND PRODUCED POSITIVE RESULTS. CONFIRMATION TESTING WITH THE ID NOW COVID-19 2.0 ASSAY WAS PERFORMED THE SAME DAY AS THE RAPID SELF-TEST WITH NASAL SWABS AND GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED THE PATIENTS WERE SYMPTOMATIC AT THE TIME OF TESTING AND THAT NO REPEAT OR ADDITIONAL TESTING WAS PERFORMED. THE CUSTOMER INDICATED THAT THAT THE PATIENTS WERE NOT PRESCRIBED PAXLOVID AND THAT THEIR SYMPTOMS WORSENED (FEVER, BODY ACHES, CHILLS, COUGH, SORE THROAT, HEADACHES, RUNNY NOSE, NASAL CONGESTION). THE CUSTOMER DID NOT REPORT IF ANY TREATMENT OR MEDICAL INTERVENTION WAS REQUIRED. THE CURRENT HEALTH STATUS OF THE PATIENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS OBTAINED.
Patient problems: Insufficient Information
MAUDE report 23039043 ↗MalfunctionOct 11, 2024False Negative Result; False Negative Result
THE CUSTOMER REPORTED FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 2.0 TEST KIT PERFORMED ON (B)(6) 2024 USING NASAL SAMPLE. CONFIRMATION TESTING WAS PERFORMED ON SAME DAY WITH PCR METHOD USING NASOPHARYNGEAL SAMPLE THAT GENERATED POSITIVE RESULT. 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 20431286 ↗MalfunctionSep 16, 2024Non Reproducible Results; Non Reproducible Results
THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY FOR TWO PATIENTS PERFORMED ON MULTIPLE DATES. THIS MANUFACTURER REPORT ADDRESSES PATIENT ONE (1) OF TWO (2). THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2024. THE CUSTOMER TESTED THE SAME PATIENT SAMPLE IN TWO SEPARATE INSTRUMENTS ON THE SAME DAY. THE FIRST TEST RETURNED A NEGATIVE RESULT, AND THE SECOND TEST RETURNED A POSITIVE RESULT. THE PATIENT WAS REPORTED TO HAVE BEEN COVID-19 POSITIVE 9 DAYS PRIOR TO TESTING. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20232462 ↗MalfunctionSep 16, 2024Non Reproducible Results; Non Reproducible Results
THE CUSTOMER REPORTED A CONFLICTING RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2024. THIS REPORT IS FOR PATIENT TWO (2) OF TWO (2). THE CUSTOMER TESTED THE SAME PATIENT SAMPLE IN THE SAME SAMPLE RECEIVER IN TWO SEPARATE INSTRUMENTS ON THE SAME DAY. THE FIRST INSTRUMENT RETURNED A NEGATIVE RESULT, AND THE SECOND INSTRUMENT RETURNED A POSITIVE RESULT. THE PATIENT WAS REPORTED TO HAVE NO SYMPTOMS BUT WAS EXPOSED TO THE COVID-19 VIRUS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20231662 ↗MalfunctionAug 12, 2024False Negative Result; False Negative Result
THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2024 ON A NASAL KITTED SWAB. CONFIRMATION TESTING WAS PERFORMED AT A HOSPITAL VIA PCR ON THE SAME DATE WHICH PRODUCED A POSITIVE RESULT. 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 19959676 ↗MalfunctionJun 28, 2024False Positive Result; False Positive Result
THE CUSTOMER REPORTED FIVE (5) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY 2.0 PERFORMED ON MULTIPLE PATIENTS ON AN UNKNOWN DATE ON UNKNOWN SAMPLE TYPES. THIS MFR. REPORT ADDRESSES TEST FIVE (5) OF FIVE (5). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY 2.0 PERFORMED ON AN UNKNOWN DATE ON AN UNKNOWN SAMPLE TYPE. CONFIRMATION TESTING WAS PERFORMED VIA PCR (PLATFORM: UNKNOWN) ON THE SAME DAY WHICH GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19639625 ↗MalfunctionJun 28, 2024False Positive Result; False Positive Result
THE CUSTOMER REPORTED FIVE (5) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY 2.0 PERFORMED ON MULTIPLE PATIENTS ON AN UNKNOWN DATE ON UNKNOWN SAMPLE TYPES. THIS MFR. REPORT ADDRESSES TEST FOUR (4) OF FIVE (5). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY 2.0 PERFORMED ON AN UNKNOWN DATE ON AN UNKNOWN SAMPLE TYPE. CONFIRMATION TESTING WAS PERFORMED VIA PCR (PLATFORM: UNKNOWN) ON THE SAME DAY WHICH GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19639618 ↗MalfunctionJun 28, 2024False Positive Result; False Positive Result
THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2024 ON A NASAL SAMPLE USING THE KIT SWAB. THIS MANUFACTURER¿S REPORT ADDRESSES TEST TWO (2) OF TWO (2) FOR PATIENT ONE (1) OF THREE (3). THE CUSTOMER PERFORMED AN ADDITIONAL TEST ON THE SAME DAY ON A DIFFERENT ID NOW INSTRUMENT AND GENERATED A NEGATIVE RESULT. 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 19637604 ↗MalfunctionJun 28, 2024False Positive Result; False Positive Result
THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6)2024 ON A NASAL SAMPLE USING THE KIT SWAB. THIS MANUFACTURER¿S REPORT ADDRESSES PATIENT TWO (2) OF THREE (3). THE CUSTOMER PERFORMED AN ADDITIONAL TEST ON THE SAME DAY ON A DIFFERENT ID NOW INSTRUMENT AND GENERATED A NEGATIVE RESULT. 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 19637508 ↗MalfunctionJun 28, 2024False Positive Result; False Positive Result
THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2024 ON A NASAL SAMPLE USING THE KIT SWAB. THIS MANUFACTURER¿S REPORT ADDRESSES TEST TWO (2) OF TWO (2) FOR PATIENT THREE (3) OF THREE (3). THE CUSTOMER PERFORMED AN ADDITIONAL TEST ON THE SAME DAY ON A DIFFERENT ID NOW INSTRUMENT AND GENERATED A NEGATIVE RESULT. 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 19637057 ↗MalfunctionJun 28, 2024False Positive Result; False Positive Result
THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2024 ON A NASAL SAMPLE USING THE KIT SWAB. THIS MANUFACTURER¿S REPORT ADDRESSES TEST ONE (1) OF TWO (2) FOR PATIENT ONE (1) OF THREE (3). THE CUSTOMER PERFORMED AN ADDITIONAL TEST ON THE SAME DAY ON A DIFFERENT ID NOW INSTRUMENT AND GENERATED A NEGATIVE RESULT. 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 19636864 ↗MalfunctionJun 28, 2024False Positive Result; False Positive Result
THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2024 ON A NASAL SAMPLE USING THE KIT SWAB. THIS MANUFACTURER¿S REPORT ADDRESSES TEST ONE (1) OF TWO (2) FOR PATIENT THREE (3) OF THREE (3). THE CUSTOMER PERFORMED AN ADDITIONAL TEST ON THE SAME DAY ON A DIFFERENT ID NOW INSTRUMENT AND GENERATED A NEGATIVE RESULT. 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 19636768 ↗MalfunctionJun 21, 2024False Negative Result; False Negative Result
THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2024 WITH A NASAL SAMPLE. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT AFTER FEELING UNWELL WITH COVID SYMPTOMS AFTER THE ID NOW TEST WAS PERFORMED. PCR CONFIRMATION TESTING (SAMPLE TYPE UNKNOWN) WAS PERFORMED AT A HOSPITAL ON THE SAME DAY AND GENERATED A POSITIVE RESULT. AFTER THE PCR TEST THE PATIENT RECEIVED TREATMENT. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19589911 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K221925. One submission often covers many models, so check the product and lot details in each record.
- Z-1571-2025 · Mar 4, 2025 · Open, ClassifiedBrand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To De
- Z-1574-2025 · Mar 4, 2025 · Open, ClassifiedBrand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To De
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page