The cobas z 480 analyzer including dedicated software for IVD use is… — Class II medical device recall Z-0846-2021
Terminated recall by Roche Molecular Systems, Inc., reported 2021-01-20, distributed nationwide. Dirty Lens May Cause Invalid or False Positive Results
| Recall number | Z-0846-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Molecular Systems, Inc., Branchburg, NJ, United States |
| Recall initiated | 2020-11-19 |
| Classified | 2021-01-12 |
| Reported by FDA | 2021-01-20 |
| Terminated | 2023-08-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, AW, BB, BE, BG, BR, BS, BZ, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DZ, EC, EE, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JM, JP, KR, LB, LK, LT, MA, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TW, UA, UY, VE, VN, ZA |
| UPC / GTIN / UDI-DI | 04015630929016 |
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 for recall
Dirty Lens May Cause Invalid or False Positive Results
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0846-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.