A1CNow® Self Check Test System 3070Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00381933070019), received between Jan 19, 2022 and Sep 20, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Body Fluid” (1 report).

7 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED RECEIVING A LOW A1C RESULT FROM THEIR A1C NOW SELF CHECK KIT IN COMPARISON TO A LAB RESULT FROM OVER A MONTH PRIOR. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20270179 ↗
• MalfunctionJul 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THAT WHEN ATTEMPTING TO PERFORM A TEST WITH THEIR A1C KIT, THE SHAKER SOLUTION SPLASHED ONTO THEIR FACE UPON COLLECTOR INSERTION. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM DURING OR AFTER THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19670761 ↗
• MalfunctionMay 9, 2024Low Readings; Low Readings

  THE CUSTOMER REPORTED RECEIVING A PATIENT RESULT OF 5.0% A1C HOWEVER THE RESULT IS NOT BELIEVABLE AS THE PATIENT IS REPORTED TO BE A KNOWN DIABETIC. THE CUSTOMER ALSO PROVIDED CONTINUOUS GLUCOSE MONITOR RESULTS (NO A1C LAB AVAILABLE). THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280113 ↗
• MalfunctionSep 29, 2023Display Difficult to Read; Display Difficult to Read

  THE CUSTOMER REPORTED THEIR ANALYZER LCD SCREEN DISPLAYING FOUR X'S (ALL LCD SEGMENTS ILLUMINATED). ADDITIONALLY WHEN TESTING THEY WERE ABLE TO RECEIVE A NUMBER THEY BELIEVED TO BE EITHER 9.4% OR 9.7% A1C. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THIS INCIDENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE INVESTIGATION RESULTS WHEN THE PRODUCT WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17848418 ↗
• MalfunctionJun 1, 2023Device Contamination with Body Fluid; Device Contamination with Body Fluid

  THE CUSTOMER ALLEGES THAT THEIR LAST CARTRIDGE POUCH ALREADY HAD SAMPLE APPLIED TO IT WHEN THEY OPENED THE POUCH. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THIS ALLEGATION IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037427 ↗
• MalfunctionJan 19, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE CUSTOMER REPORTED HAVING TROUBLE USING THEIR A1C KIT. DURING TROUBLESHOOTING THE CUSTOMER STATED THEY HAVE ONE ANALYZER BUT TWO CARTRIDGES WITH DIFFERENT CODES. ONE MATCHES THE ANALYZER, THE OTHER DOES NOT. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS. THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE CUSTOMERS REPORT OF HAVING MISMATCHED CARTRIDGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13296944 ↗

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-0223-2025 · Sep 18, 2024 · Completed
  A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilut
• Z-0683-2020 · Dec 2, 2016 · Terminated
  A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062
• Z-0686-2020 · Dec 2, 2016 · Terminated
  CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
• 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-0684-2020 · Dec 2, 2016 · Terminated
  Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056
• Z-0685-2020 · Dec 2, 2016 · Terminated
  ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
• 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