cobas Factor II and Factor V Test 07948352190Recalls & reported problems

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00875197005998), received between Jan 6, 2026 and Jan 6, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Non Reproducible Results” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Non Reproducible Results1
Unable to Obtain Readings1

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.

MalfunctionJan 6, 2026Unable to Obtain Readings; Non Reproducible Results
THERE WAS AN ALLEGATION OF A QUESTIONABLE RESULT WITH THE COBAS® FACTOR II AND FACTOR V TEST FOR A PATIENT SAMPLE TESTED ON A COBAS Z 480 ANALYZER. ON (B)(6) 2025, THE INITIAL RESULT WAS HET F2 (HETEROZYGOUS). ON (B)(6) 2025, A SECOND DRAW WAS TESTED AND THE RESULT WAS WT F2 (WILD TYPE). ON (B)(6) 2025, THE REPEAT RESULT OF THE ORIGINAL SAMPLE WAS HET F2. ON (B)(6) 2025, THE ORIGINAL SAMPLE, THE SECOND DRAW, AND ANOTHER DRAW SAMPLE WERE TESTED ON ANOTHER INSTRUMENT AND THE RESULTS WERE HET F2, ALL THREE TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23977741 ↗

Device details

UDI-DI	`00875197005998`
Brand	cobas Factor II and Factor V Test
Model	07948352190
Company	Roche Molecular Systems, Inc.
Product code	NPR · TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR
Class	Class 2
FDA submission	K172913
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2018

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

INVADER INVADER FACTOR V, 144 TESTS
Hologic, Inc. · TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR
1 report

All TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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