Alere Afinion™ AS100 1115390Recalls & reported problems
Abbott Diagnostics Technologies AS · Alere Afinion AS100 Analyzer with Alere Afinion Data Connectivity Converter (ADCC) is a compact multi-assay analyzer for point-of care testing, designed to analyze the Afinion Test Cartridges. The ADCC is a small device for automatic transfer of data, including patient and control assay results, from the Alere Afinion Analyzer to a laboratory information system or another electronic journal system. Alere Afinion AS100 Analyzer System, consisting of Alere Afinion AS100 Analyzer with Alere Afinion Data Connectivity Converter (ADCC), Afinion Test Cartridges and Afinion Controls is for in vitro diagnostic use only. Contents: 1 Alere Afinion AS100 · Class 1
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 07070060008042), received between Feb 19, 2024 and Dec 4, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (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.
Reports received per month
Most reported problems
Device problems
- Failure of Device to Self-Test1
- Noise, Audible1
- Sparking1
- Unintended Electrical Shock1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2025Failure of Device to Self-Test; Noise, Audible; Unintended Electrical Shock; Failure of Device to Self-Test; Noise, Audible; Unintended Electrical Shock
10NOV2025: CUSTOMER PHONED TECHNICAL SERVICES (TS) INFORMING THAT ONE OF THEIR PROVIDERS EMAILED ABOUT AFINION INSTRUMENT, (SN: (B)(6), MAKING A LOUD NOISE UPON START UP, THEY TRIED UNPLUGGING AND PLUGGING IT BACK IN BUT THE RED LIGHT WAS BLINKING, THE SCREEN THEN DISPLAYED A SELF-TEST ERROR, THE ANALYZER WAS IN A NONE-OPERATIVE MODE. THE CUSTOMER ALSO REPORTED THAT ONE OF THE PROVIDERS ALSO INFORMED THAT IT ALMOST SHOCKED THEM, PROBABLY WHEN THEY ARE UNPLUGGING/PLUGGING IT. THIS ONLY HAPPENED WITH 1 PROVIDER, AS WHAT THE CUSTOMER RECALLED. CUSTOMER LATER CLARIFIED THAT ELECTRICAL SHOCK WAS FROM THE POWER SUPPLY AND THEY TOUCHED THE MACHINE AND DID NOT EXPERIENCE ANY ELECTRICAL SHOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23715128 ↗MalfunctionFeb 19, 2024Sparking; Sparking
ON (B)(6) 2024 A CUSTOMER CALLED TO REPORT ERROR CODE 214 (TEST CARTRIDGE OR ANALYZER FAILURE) AND PROVIDED THE FOLLOWING PRODUCT DETAILS: ANALYZER SERIAL NUMBER: (B)(6). SOFTWARE VERSION: 7.03. CARTRIDGE TYPE: HBA1C. CARTRIDGE LOT NUMBER: NOT PROVIDED. THERE WERE NO KNOWN SHIPPING CONCERNS OR ENVIRONMENTAL CONDITION CONCERNS. THE TEMPERATURE IN THE FACILITY WAS REPORTED TO BE 68-70 DEGREES FAHRENHEIT ( 20-21 DEGREES CELSIUS). FREQUENCY OF FAILED ASSAYS: 3-4 TIMES. CUSTOMER ALSO REPORTED THAT TECH WENT OVER TO SERVICE THE AFINION INSTRUMENT, AND THERE WAS A VISIBLE ELECTRICAL SPARK FROM THE CORD. THE INCIDENT DID NOT TRIP THE CIRCUIT BREAKER, AND THE CORD WAS NOT PLUGGED INTO A SURGE PROTECTOR. TECH STOPPED WORKING ON THE ANALYZER IMMEDIATELY AND CALLED TECHNICAL SERVICES (TS) FOR ASSISTANCE. NO ONE WAS TOUCHING OR USING THE ANALYZER WHEN THE SPARK OCCURRED. THE TECH WAS WEARING RUBBER SOLED SHOES, SHORT SLEEVE SHIRT AND PANTS. THERE WAS NO ATTEMPT TO USE THE INSTRUMENT AFTER SPARKING. THE TECH WAS ADVISED NOT TO USE THE INSTRUMENT AFTER THE SPARKING EVENT. ON JANUARY 25, 2024 ADDITIONAL INFORMATION WAS RECEIVED THAT THE CUSTOMER WAS USING THE OLD POWER SUPPLY (MODEL # FRA042-F24-8
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18729398 ↗
Other Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica devices
- Afinion™ 2 1116986Abbott Diagnostics Technologies AS · Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica1 recall1 report
- Afinion™ 2 1116985Abbott Diagnostics Technologies AS · Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica2 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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