Lower riskMedical device recall · FDA · Published November 19, 2020
Roche cobas z 480 Analyzer: Dirty Lens May Cause False Positive Results
Roche recalls cobas z 480 analyzers for possible false positive results due to dirty lenses. Lab users should check lens cleanliness and follow manufacturer instructions.
“Roche cobas z 480 Analyzer: Dirty Lens May Cause False Positive Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63839-roche-cobas-z-480-analyzer-dirty-lens-may-cause-false. Based on FDA recall #Z-0846-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0846-2021%22&limit=1).
Roche Molecular Systems, Inc. recalled the cobas z 480 analyzer on Nov. 19, 2020, due to a dirty lens that may cause invalid or false positive results, according to the FDA. The agency announced the voluntary Class II recall under number Z-0846-2021.
How to tell if you have it
cobas z 480 analyzer including dedicated software for IVD use
UDI: 04015630929016
The hazard
A dirty lens may cause invalid or false positive results, according to the FDA. The cobas z 480 analyzer is a plate-based automated amplification and detection system for nucleic acids intended for in-vitro diagnostic use.
Context
GovInfoNow's records show Roche Molecular Systems, Inc. has had 10 other recalls since Oct. 27, 2017. Other recent recalls of similar products include Roche Influenza A/B & RSV Test Recall (Dec. 21, 2022), Roche cobas 5800 PCR device recall (Sept. 8, 2022), and Roche cobas LiatSystem recall (Nov. 16, 2021). Additional recent recalls of similar products include Roche cobas pro integrated solutions recall (Jan. 20, 2026) and Roche Elecsys Anti-TSHR Assay Recall (Nov. 21, 2025).
How to tell if you have this one
The cobas z 480 analyzer is used for specific medical tests like BRAF mutations and HPV detection. Check the unit's UDI number: 04015630929016.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lens Cleanliness
Inspect the lens for dirt or debris that could cause false positive results.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Canada, Germany, Italy, Spain, United Kingdom, France, Austria, Turkey, Belgium, Poland, Portugal, Greece, Netherlands, Switzerland, Czech Republic, Romania, Sweden,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.7 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-0846-2021 (November 19, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0846-2021 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.