Atellica IM Syph QC 10995676Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414599892), received between Feb 13, 2026 and Feb 13, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K112343); they may or may not involve this specific model.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Difficult to Open or Close

  THE CUSTOMER REPORTED THAT QC MATERIAL SPLASHED ONTO THE OPERATOR'S HAND AND UNDER THE GLOVE WHILE OPENING THE NEGATIVE ATELLICA IM SYPHILIS QUALITY CONTROL (SYPH QC), LOT 066 BOTTLE. THE CUSTOMER STATED THAT WHILE OPENING THE NEGATIVE QC BOTTLE BY SQUEEZING/SQUIRTING THROUGH THE TIP, THE MATERIAL SPLASHED BECAUSE THE TIP WAS NOT PRESENT. UPON INSPECTION, NO TIP WAS FOUND INSIDE THE BLUE CAP AND NO EVIDENCE OF LEAKAGE WAS OBSERVED INSIDE THE BOX. THE OTHER BOTTLE WITHIN THE SAME BOX WAS INTACT. THE CUSTOMER ALSO CHECKED ADDITIONAL BOXES, WHICH WERE FOUND TO BE ACCEPTABLE. THE MISSING TIP WAS NOT LOCATED. THE CUSTOMER STATED THAT THE OPERATOR HAD A PRE-EXISTING CUT ON THE HAND BENEATH THE GLOVE (NOT RELATED TO THIS EVENT), WHICH CAME INTO CONTACT WITH THE QC MATERIAL. DAY-ZERO SCREENING FOR HIV, HEPATITIS, AND SYPHILIS WAS PERFORMED, AND FOLLOW-UP TESTING TO BE PERFORMED IN 3 MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338703 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112343. One submission often covers many models, so check the product and lot details in each record.

• Z-1674-2021 · Apr 21, 2021 · Open, Classified
  Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma
• Z-2228-2012 · Jul 17, 2012 · Terminated
  Siemens ADVIA Centaur Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) assay is an in vitro diagnostic immunoass