Alere Afinion™ HbA1c 1115015Recalls & reported problems
Abbott Diagnostics Technologies AS · Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood. Contents: 15 Test Cartridges. 1 Package Insert. DI covers Alere Afinion HbA1c and Afinion HbA1c. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07070060005683), received between May 4, 2018 and Aug 16, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “High Readings” (1 report).
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
Device problems
- High Readings1
- Incorrect Or Inadequate Test Results1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 16, 2018High Readings; High Readings
A CUSTOMER REPORTED DISCREPANT RESULTS FOR THE ALERE AFINION HBA1C ON THE ALERE AFINION AS100 INSTRUMENT COMPARED TO AN UNKNOWN LABORATORY METHOD: ALERE AFINION HBA1C: 10.6% UNKNOWN LABORATORY METHOD: 5.1 % BOTH SAMPLES WERE COLLECTED FROM THE SAME DRAW. THE SAMPLE WAS SENT TO AN EXTERNAL LAB BECAUSE THE RESULT WITH AFINION HBA1C WAS HIGHER THAN EXPECTED. THE CUSTOMER WAS NOT ABLE TO REPLICATE THE RESULT. A SAMPLING OF TEST CARTRIDGES FROM THIS SPECIFIC LOT WERE BEEN EXAMINED FOR MALFUNCTION WITH NOEN OBSERVED. NO DEVIATIONS WERE OBSERVED IN THE HANDLING AND STORAGE OF SAMPLES INSTRUMENT OR TEST CARTRIDGES AT THE CUSTOMER SITE. THERE IS NO INFORMATION AVAILABLE ON THE LABORATORY INSTRUMENT USED FOR COMPARISON.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7791244 ↗MalfunctionMay 4, 2018Incorrect Or Inadequate Test Results
DISCREPANT (B)(6) RESULTS COMPARED TO LAB: 5 PATIENT SAMPLES/ 1 ANALYZER. CUSTOMER REPORTED 5 DISCREPANT PATIENT RESULTS: (B)(6). LAB SAMPLES WERE VENOUS DRAW PURPLE TOP TUBES- NO TEST DATES OR FURTHER INFORMATION REGARDING THE LAB RESULTS WERE PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7486437 ↗
Other Assay, Glycosylated Hemoglobin devices
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- A1CNow®+ Multi-UseTest System (20 count) 3021Polymer Technology Systems, Inc. · ASSAY, GLYCOSYLATED HEMOGLOBIN1 recall11 reports
- ADVIA® Chemistry FRUC Reagents 10361941Siemens Healthcare Diagnostics Inc. · ASSAY, GLYCOSYLATED HEMOGLOBIN1 recall0 reports
- DCA™ Systems Hemoglobin A1c Reagent Kit 10311134Siemens Healthcare Diagnostics Inc. · ASSAY, GLYCOSYLATED HEMOGLOBIN1 recall0 reports
- Tinaquant Hemoglobin A1c III 5336163190Roche Diagnostics GmbH · ASSAY, GLYCOSYLATED HEMOGLOBIN45 reports
- Tina-quant Hemoglobin A1cDx Gen.3 08445699190Roche Diagnostics GmbH · ASSAY, GLYCOSYLATED HEMOGLOBIN11 reports
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.
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