Afinion 2Recalls & reported problems across all models

We found 2 models of Afinion 2 by Abbott Diagnostics Technologies AS in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Nov 17, 2023 and Mar 12, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Smoking” (2 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Afinion 2 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. 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 · Recall details · FDA record ↗

Most reported Afinion 2 problems

Afinion 2 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Afinion™ 2 1116986

  Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
  1 recall1 report
• Afinion™ 2 1116985

  Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
  2 reports

Recent Afinion 2 adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2025Sparking; Sparking

  ON 14 FEB 2025 ABBOTT TECHNICAL CONSULTANT (TC) CALLED TECHNICAL SERVICES (TS) TO REPORT AN ISSUE FROM A CUSTOMER. THE CUSTOMER HAD INFORMED TC OF THE FOLLOWING; WHEN THEY CAME IN THIS MORNING, THEIR 2 AFINION 2 INSTRUMENTS (BOTH SITTING ON A COUNTER) WERE FINE. WHEN SOMEONE CAME IN THE ROOM, THEY NOTICED THAT THERE WAS SOMETHING LEAKING (LIKE BLACK COFFEE) UNDERNEATH THE 1 ANALYZER. WHEN THEY NOTICED IT, THE INSTRUMENT SUDDENLY SHUT OFF. THE INSTRUMENTS INVOLVED WERE: (B)(6) - INSTRUMENT IN QUESTION. (B)(6) - WORKING FINE. TS CONTACTED THE CUSTOMER AND RECEIVED THE FOLLOWING UPDATE: JUST TO SUMMARIZE - WE HAD 1 OF THE A1C MACHINES OFF ON ITS OWN WHEN I CAME IN THIS MORNING AND A LEAK THAT LOOKED LIKE A COFFEE STAIN UNDERNEATH BOTH MACHINES. WHEN FURTHER EXAMINING, SAW THE BATTERY PACK OF ONE OF THE MACHINES WAS LEAKING BATTERY ACID. IT ALSO SPARKED IN THE PROCESS. WE SHUT OFF THE WHOLE POWER SUPPLY IN THAT AREA AND HAD OUR BIOMED DEPARTMENT COME OVER AND ASSESS THE SPILL. THEY REMOVED THE BATTERY PACKS FROM BOTH MACHINES AND SAID WE NEED THOSE REPLACED. I AM AFRAID WE MIGHT NEED BOTH MACHINES REPLACED AS THEY WERE BOTH SITTING IN THE BATTERY ACID AND AM UNSURE WHAT WAS DAMAGED. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586475 ↗
• 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 ↗
• MalfunctionNov 17, 2023Smoking; Sparking; Smoking; Sparking

  13-NOV-2023: THE TECHNICAL CONSULTANT EMAILED TECHNICAL SERVICES (TS). THE CUSTOMER REPORTED SPARK COMING FROM THE CARTRIDGE HOLDER/COMPARTMENT OF THEIR AFINION 2, RIGHT AFTER THERE WAS A SMELL OF BURNT. WE HAVE POWERED OFF THE MACHINE. THE CUSTOMER ALSO PROVIDED THE FOLLOWING INFORMATION: SERIAL NUMBER: (B)(6).   SOFTWARE VERSION: W 21.14  NO HARM TO USER CIRCUIT BREAKER DID NOT TRIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158356 ↗