Food, drugs, devices › Roche Molecular Systems, Inc.
Device recall: The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection
FDA enforcement event 86879 is a device recall by Roche Molecular Systems, Inc. of Branchburg, NJ, initiated 19 Nov 2020 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 10 Aug 2023. Initiation: voluntary: firm initiated. Roche Molecular Systems, Inc. has 30 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Roche Molecular Systems, Inc., Branchburg, NJ.
Reason for recall
"Dirty Lens May Cause Invalid or False Positive Results"
Distribution
"Worldwide distribution - US Nationwide distribution and the countries of Canada, Germany, Italy, Spain, United Kingdom, France, Austria, Turkey, Belgium, Poland, Portugal, Greece, Netherlands,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0846-2021 | The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as an in-vitro diagnostic or screening system providing real time PCR amplification and detection for human samples within the system.… | 597 units US; 3411 units OUS | Class II | Terminated | 20 Jan 2021 |
Context
Other enforcement events for Roche Molecular Systems, Inc.
All 30 events for Roche Molecular Systems, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Dirty Lens May Cause Invalid or False Positive Results"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide distribution and the countries of Canada, Germany, Italy, Spain, United Kingdom, France, Austria, Turkey, Belgium, Poland, Portugal, Greece, Netherlands,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Aug 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.