Well at Walgreens 3056Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00311917169835), received between Jan 12, 2024 and Jan 12, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Readings” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2024Low Readings; Low Readings

  THE CUSTOMER REPORTED RECEIVING AN A1C VALUE OF 5.0% IN COMPARISON TO THEIR LAB VALUE OF 9.0% A COUPLE DAYS LATER. 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 18504570 ↗

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-0686-2020 · Dec 2, 2016 · Terminated
  CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
• 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-0685-2020 · Dec 2, 2016 · Terminated
  ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
• Z-0683-2020 · Dec 2, 2016 · Terminated
  A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062
• 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