Afinion™ 2 1116986Recalls & reported problems
Abbott Diagnostics Technologies AS · Afinion 2 is a compact, fully automated, multi-assay analyzer for professional near-patient testing and laboratory use. Afinion 2 is designed for use with the Afinion Test Cartridges only. The Afinion 2 System, consisting of Afinion 2 Analyzer with Afinion Test Cartridges and Afinion Controls, is intended for in vitro diagnostic use only. Contents: 1 Afinion 2 Analyzer · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07070060014708), received between Oct 25, 2024 and Oct 25, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Noise, Audible” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Jun 17, 2024Open, Classified
Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.
Z-2736-2024 · Root cause: Reprocessing Controls · FDA record ↗
Most reported problems
Device problems
- Noise, Audible1
- Smoking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2024Smoking; Noise, Audible; Smoking; Noise, Audible
ON (B)(6) 2024 THE CUSTOMER SENT TECHNICAL SERVICES (TS) AN EMAIL, THEIR AFINION 2 (SN (B)(6)) WAS SMELLING VERY HOT AND SMOKING WHILE RUNNING A TEST. THE CUSTOMER HAD ALREADY UNPLUGGED THE MACHINE AND STOPPED USING IT. ON (B)(6) 2024 CUSTOMER CONFIRMED: THE POWER CORD WAS BLACK AND BLUE COLOR WITH SERIAL NO. (B)(6). THERE WAS A SMALL AMOUNT OF SMOKE, THE LOCATION FROM WHERE IT CAM COULD NOT BE IDENTIFIED AND THE HOT SMELL WAS LIKE BURNING PLASTIC. IN ADDITION TO THIS THE CUSTOMER ALSO CONFIRMED THERE WAS A TERRIBLE NOISE FROM THE INSTRUMENT. CUSTOMER CONFIRMED THE INCIDENT DID NOT CAUSE DEATH OR ANY INJURY. THE INSTRUMENT WAS SET UP IN A SUITABLE ENVIRONMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20531136 ↗
Other Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica devices
- Afinion™ 2 1116985Abbott Diagnostics Technologies AS · Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica2 reports
- Alere Afinion™ AS100 1115390Abbott Diagnostics Technologies AS · Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.