FDA Device recall 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…
- FDA Device
- Class II
- terminated
- Published 2021-01-20
On 2021-01-20 the FDA classified a Class II recall of The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic… by Roche Molecular Systems, citing dirty Lens May Cause Invalid or False Positive Results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0846-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-19 |
| Published | 2021-01-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roche Molecular Systems |
| Distribution | US |
Product
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. The cobas x 480 instrument and cobas z 480 analyzer are to be used by laboratory professionals trained in laboratory techniques and by instruction on the use of the system and analyzer. In the U.S. the cobas z 480 analyzer is used for automated amplification and detection purposes for the following assays: cobas¿ 4800 BRAF V600 Mutation Test cobas¿ Cdiff Test for use on the cobas¿ 4800 System cobas¿ CT/NG v2.0 Test cobas¿ EGFR Mutation Test v2 cobas¿ Factor II and Factor V Test cobas¿ 4800 HPV Test cobas¿ HSV 1 and 2 Test for use on the cobas¿ 4800 System cobas¿ KRAS Mutation Test cobas¿ MRSA/SA Test for use on the cobas¿ 4800 System
Reason
Dirty Lens May Cause Invalid or False Positive Results
Identifiers
| code_info | All units UDI: 04015630929016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0846-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.