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INVADER INVADER FACTOR II, 144 TESTSRecalls & reported problems

Hologic, Inc. · Class 2

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 15420045506558), received between Jan 11, 2018 and Jan 11, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Improper or Incorrect Procedure or Method1
  • Incorrect Or Inadequate Test Results1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • InjuryJan 11, 2018Improper or Incorrect Procedure or Method; Incorrect Or Inadequate Test Results

    (B)(6), CUSTOMER, HAD DISCREPANT RESULTS FOR TEN SAMPLES THAT WERE MANUALLY TESTED WITH THE FACTOR II ASSAY. THE CUSTOMER RAN A FACTOR II ASSAY ON (B)(6) 2017 CONTAINING TEN SAMPLES, TWO SAMPLES PROVIDED CARRIER/HETEROZYGOUS (HET) RESULTS, AND EIGHT SAMPLES PROVIDED NEGATIVE/HOMOZYGOUS WILD TYPE (WT) RESULTS. THE FACTOR II ASSAY RESULTS FROM (B)(6) 2017 WERE QUESTIONED AND THE CUSTOMER RE-TESTED THE ORIGINAL TEN FACTOR II SAMPLES ON (B)(6) 2017, AND ALL RESULTS WERE WT. THE CUSTOMER STATED THAT THE DISCREPANT RESULTS WERE LIKELY CAUSED BY AN OPERATOR ERROR WHICH IMPACTED THE ORIGINAL RUN PERFORMED ON (B)(6) 2017. THE CUSTOMER FREQUENTLY TESTS THE FACTOR V AND FACTOR II ASSAYS CONCURRENTLY, ON THE SAME ASSAY PLATE, USING THE SAME SAMPLES; SO THE CUSTOMER BELIEVES THE FACTOR V OLIGO MIX WAS USED FOR THE FACTOR II ASSAY. ALTHOUGH THE FACTOR V ASSAY WAS LIKELY PERFORMED USING THE INCORRECT OLIGO MIX, THE ASSAY WAS VALID. IT WAS EMPHASIZED TO CUSTOMER THAT THE FACTOR II AND FACTOR V CONTROLS ARE NOT INTERCHANGEABLE. THE CONTROLS FROM THE FACTOR II KIT SHOULD BE USED WITH THE FACTOR II REAGENTS AND SAME FOR THE FACTOR V CONTROLS AND REAGENTS. HOLOGIC EVALUATED THIS ISSUE AND DETERMINED T

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7182084 ↗

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.