Afinion™ 2 1116985Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07070060014692), received between Nov 17, 2023 and Mar 12, 2025 — classified as 2 malfunctions.

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

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, 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 ↗
• 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 ↗