ReliOn™ 2CT A1C Meter 3055Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00681131403252), received between May 5, 2023 and May 5, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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.

• MalfunctionMay 5, 2023Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT UPON OPENING THEIR A1C SELF-CHECK KIT, THEY OBSERVED THAT TWO LANCETS HAD BEEN USED AND A BLOOD COLLECTOR THAT WAS PRESENT HAD BEEN USED ALSO. THE CUSTOMER ALSO NOTED THAT THE BOX HAD BEEN SLICED OPEN AND TAPED BACK (USED AND RE-SEALED). THE CUSTOMER DID NOT ATTEMPT TO USE ANY OF THE PRODUCT AND REPORTED NO USER WAS HURT OR INJURED. THIS ALLEGATION IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876397 ↗

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-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-0683-2020 · Dec 2, 2016 · Terminated
  A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062
• 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-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