cobas e 801 immunoassay analyzer — Class II medical device recall Z-1249-2019
Terminated recall by Roche Diagnostics Corporation, reported 2019-05-08, distributed in AL, AZ, CA, CT, FL, HI, IA, IL…. The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle
| Recall number | Z-1249-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2019-03-15 |
| Classified | 2019-05-02 |
| Reported by FDA | 2019-05-08 |
| Terminated | 2020-04-23 |
| Distributed | AL, AZ, CA, CT, FL, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NY, OH, OR, PA, PR, SC, TN, TX, VA, WA, WI |
| Quantity | 149 |
Product
cobas e 801 immunoassay analyzer
Reason for recall
The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment.
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-1249-2019. 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.