A1CNow®+ Multi-UseTest System (20 count) 3021Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00381933021011), received between Jun 11, 2021 and Dec 12, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 reports).

1 FDA recall record name this device's identifier.

6 other recalls cover devices cleared under the same FDA submission (K090413); 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.

Recalls naming this device

1. Sep 18, 2024Class IICompleted

   The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may result in inaccurate test results as components within each lot number are meant to be used together, and not mixed between lots. Therefore, the test results may possibly lead to Hemoglobin A1C positive or negative bias results. While the product is for monitoring only, over recovery with a higher than accurate value can be an indication for increased therapy; such as physical activity, weight reduction, meal management, pharmaceutical therapy.

   Z-0223-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE CUSTOMER REPORTED THAT THE PRINTED CODE ON THEIR CARTRIDGE (BA) DID NOT MATCH THE PRINTED CODE ON THE ANALYZER (BH). THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS (THE CUSTOMER DID NOT PROCEED WITH TESTING).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20918997 ↗
• MalfunctionDec 6, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED UNDER-RECOVERY OF TWO A1CNOW+ KIT RESULTS WHEN COMPARED TO LAB VALUES. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20872115 ↗
• MalfunctionNov 27, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED RECEIVING LOW A1C KIT RESULTS WHEN TESTING ON A KNOWN DIABETIC. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797199 ↗
• MalfunctionAug 21, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED INCONSISTENT A1C RESULTS WHEN COMPARING THE A1C KIT VALUES TO A RECENT LAB VALUE. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20014108 ↗
• MalfunctionMar 15, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT WHEN COMPARING TWO A1C KITS THAT THE RESULTS WERE NOT ACCURATE. THE CUSTOMER REPORTED ONE KIT REPORTED 7.4% AND ONE KIT REPORTED 6.1%. THE CUSTOMER DID NOT PROVIDE ANY LABORATORY DATA FOR REFERENCE. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18917706 ↗
• MalfunctionSep 17, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE CUSTOMER REPORTED A PATIENT WHO TESTED AT 7.6% HBA1C ON THE A1C TEST KIT AND WENT TO THE DOCTOR THREE DAYS LATER AND RECEIVED A RESULT OF 11.6% HBA1C. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12490600 ↗
• MalfunctionSep 2, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE CUSTOMER SENT A REQUEST FOR TRAINING BASED ON ACCURACY ALLEGATIONS OF HBA1C. CUSTOMER STATED THEY RECALL ONE INSTANCE WHERE THE RESULT DIFFERED BY 1-2% COMPARED TO A SAME-DAY LAB TEST. ANOTHER INSTANCE THE CUSTOMER RECALLED DID NOT INCLUDE LAB RESULT FOR COMPARISON BUT STATED THAT A DIABETIC PATIENT WAS APPROXIMATELY 4% LOWER THAN THEY EXPECTED. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12417712 ↗
• MalfunctionJul 30, 2021Image Display Error/Artifact; Image Display Error/Artifact

  THE CUSTOMER REPORTED THAT WHILE EVALUATING THE ANALYZER FOR USE THEY NOTICED THAT WHEN THE RESULTS WERE DISPLAYED, THE ANALYZER SHOWED THE RESULTS WITHOUT A DECIMAL POINT. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252516 ↗
• MalfunctionJun 30, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE CUSTOMER REPORTED ACCURACY CONCERNS WHEN USING THE A1CNOW+. THE CUSTOMER REPORTED RECEIVING A RESULT OF 12.6% ON THE A1CNOW+ COMPARED TO A LAB RESULTS OF 6% ON THE SAME DAY. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12092421 ↗
• MalfunctionJun 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED RECEIVING INACCURATE TEST RESULTS WHEN USING THE A1CNOW+ KIT WITH UP TO 3% VARIATION WHEN COMPARED TO A LAB DRAW. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12092411 ↗
• MalfunctionJun 11, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THE ANALYZER WAS NOT DISPLAYING RESULTS IN NGSP UNITS AS PRINTED ON THE ANALYZER. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11983789 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090413. One submission often covers many models, so check the product and lot details in each record.

• Z-0683-2020 · Dec 2, 2016 · Terminated
  A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062
• Z-0685-2020 · Dec 2, 2016 · Terminated
  ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
• Z-0684-2020 · Dec 2, 2016 · Terminated
  Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056
• Z-0682-2020 · Dec 2, 2016 · Terminated
  A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058
• Z-0686-2020 · Dec 2, 2016 · Terminated
  CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
• Z-0136-2014 · Aug 26, 2013 · Terminated
  Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by