FDA Device recall Z-1249-2019
cobas e 801 immunoassay analyzer
- FDA Device
- Class II
- terminated
- Published 2019-05-08
On 2019-05-08 the FDA classified a Class II recall of cobas e 801 immunoassay analyzer by Roche Diagnostics, citing 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 respe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1249-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-15 |
| Published | 2019-05-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roche Diagnostics |
| Distribution | 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 |
Product
cobas e 801 immunoassay analyzer
Reason
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.
Identifiers
| code_info | All units may experience this issue. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1249-2019%22
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