INVADER INVADER FACTOR V, 144 TESTSRecalls & reported problems

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 15420045506664), received between Dec 28, 2017 and Dec 28, 2017 — 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, Inadequate or Imprecise Result or Readings1

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.

InjuryDec 28, 2017Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method
(B)(6), CUSTOMER, REPORTED THAT THEY HAD DISCREPANT RESULTS FOR THREE SAMPLES THAT WERE MANUALLY TESTED WITH THE FACTOR V ASSAY. THE CUSTOMER RAN A FACTOR V ASSAY WITH NINE SAMPLES ON (B)(6) 2017 USING LN 189419, AND ALL NINE SAMPLES PROVIDED NEGATIVE/HOMOZYGOUS WILD TYPE (WT) RESULTS. RESULTS WERE REPORTED OUT. AFTER A SINGLE RESULT FROM THE RUN WAS QUESTIONED, THE CUSTOMER RE-TESTED ALL NINE SAMPLES ON (B)(6) 2017 USING LN 217190. IT IS NOT KNOWN WHETHER THE CUSTOMER RE-EXTRACTED THE ORIGINAL SAMPLES PRIOR TO TESTING ON (B)(6) 2017, OR IF THE PREVIOUSLY EXTRACTED SAMPLES FROM (B)(6) 2017 WERE RE-TESTED ON (B)(6) 2017. THE RE-TESTING PROVIDED SIX WT RESULTS, TWO CARRIER/HETEROZYGOUS (HET) RESULTS, AND ONE HOMOZYGOUS MUTANT (MUT) RESULT. THE CUSTOMER STATED THAT THE DISCREPANT RESULTS WERE LIKELY CAUSED BY AN OPERATOR ERROR WHICH IMPACTED THE ORIGINAL RUN PERFORMED ON 10/4/17. 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 II OLIGO MIX WAS USED FOR THE FACTOR V ASSAY. ALTHOUGH THE FACTOR V ASSAY WAS LIKELY PERFORMED USING THE INCORRECT OLIGO MIX, THE ASSAY WAS VALID.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7151944 ↗

Device details

UDI-DI	`15420045506664`
Brand	INVADER
Model	INVADER FACTOR V, 144 TESTS
Catalog no.	95-453
Company	Hologic, Inc.
Product code	NPR · TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	May 21, 2024

Device type (GMDN): Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)

A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited thrombophilia, which may be associated with, but not limited to, the prothrombin 20,210 mutation and/or the Factor V Leiden mutation (activated protein C resistance), using a nucleic acid technique (NAT).

Other TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR devices

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