Skip to content

Vysis 05J38-010Recalls & reported problems

Abbott Molecular Inc. · AneuVysion DNA Probe Kit · Class 2

All models of Vysis (9)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884999011694), received between Jun 14, 2022 and Jun 14, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “False Positive Result” (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.

Most reported problems

Device problems

  • False Positive Result1
  • Off-Label Use1

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.

  • InjuryJun 14, 2022False Positive Result; Off-Label Use; False Positive Result; Off-Label Use

    ON (B)(6) 2022, THE FDA FORWARDED MEDWATCH FORM MW5109350 TO ABBOTT MOLECULAR. A PATIENT FILED A REPORT WITH THE FDA ON (B)(6) 2022, FOR AN OTHER SERIOUS OR IMPORTANT MEDICAL EVENT THAT OCCURRED ON (B)(6) 2022. THE DESCRIPTION OF THE EVENT STATES: I HAD A POSITIVE SCREEN ON MY NIPT (NONINVASIVE PRENATAL TESTING) FOR TRISOMY 21. CHOSE TO DO INVASIVE TESTING, WHICH PROVED TO BE INACCURATE. IT IS UNKNOWN WHAT SAMPLE TYPE WAS USED, HOW THE PROTOCOL WAS CARRIED OUT, HOW THE RESULT WAS REPORTED, AND WHEN AMNIOCENTESIS WAS ORDERED. THE IMPACT ON PATIENT MANAGEMENT IS NOT KNOWN. THE AGENCY DID NOT PROVIDE THE NAME OF THE TESTING FACILITY WHERE THE TEST WAS CARRIED OUT. THE SPECIFIC PRODUCT NAME USED IN THE TEST WAS NOT PROVIDED EITHER. HOWEVER, THE FORM LISTS THE BRAND NAME AS NIPT AND THE MANUFACTURER AS ABBOTT MOLECULAR. THE ANEUVYSION MULTICOLOR DNA PROBE KIT IS NOT A NIPT OR NIPS (NONINVASIVE PRENATAL SCREENING). NONINVASIVE PRENATAL TESTING (NIPT), SOMETIMES CALLED NONINVASIVE PRENATAL SCREENING (NIPS), IS A METHOD OF DETERMINING THE RISK THAT THE FETUS WILL BE BORN WITH CERTAIN GENETIC ABNORMALITIES. THIS TESTING ANALYZES SMALL FRAGMENTS OF DNA THAT ARE CIRCULATING IN A PREGNANT WOMA

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14690649 ↗

Other Dna-probe kit, human chromosome devices

All Dna-probe kit, human chromosome devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page