Lower riskMedical device recall · FDA · Published September 8, 2022
Roche cobas 5800 PCR device may give false positive results
Roche recalls cobas 5800 PCR instruments with Material No. 08707464001 due to reported false positives and invalid results, potentially causing delayed diagnoses.
“Roche cobas 5800 PCR device may give false positive results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60079-roche-cobas-5800-pcr-device-may-give-false-positive-results. Based on FDA recall #Z-0097-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0097-2023%22&limit=1).
Roche Molecular Systems, Inc. recalled the cobas 5800 instrument due to a hazard of false positive and invalid results, according to the FDA on September 8, 2022.
How to tell if you have it
Brand: Roche
Product: cobas 5800 instrument
Material No.: 08707464001
Device Identifier: 07613336170076
Serial IDs: All serial IDs are affected
The hazard
The recalled devices may produce false positive and invalid results due to anomalous baselines, which can lead to erroneous or delayed diagnoses.
Context
GovInfoNow's records show Roche Molecular Systems, Inc. has had 10 other recalls since October 27, 2017. Other recent recalls of similar products include the Roche cobas SARS-CoV-2 & Flu Assay recall on December 21, 2022, and the Roche cobas LiatSystem recall on November 16, 2021. Additional similar recalls include the Roche cobas EGFR Mutation Test v2 recall on September 3, 2021, the Roche cobas pro integrated solutions recall on January 20, 2026, and the Roche Elecsys Anti-TSHR Assay recall on November 21, 2025.
How to tell if you have this one
Check for the device serial number starting with 07613336170076. The affected model is the cobas 5800 instrument with Material No. 08707464001.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Serial Number
Look for the serial number starting with 07613336170076 on the cobas 5800 instrument.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0097-2023 (September 8, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0097-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.