Recall Z-1249-2019— Roche Diagnostics Corporation
Class II · Terminated
Class II FDA medical device recall by Roche Diagnostics Corporation, initiated 2019-03-15, terminated 2020-04-23. It names 3 FDA 510(k) clearances: K163569, K162606, K100853. 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..
- Recalling firm
- Roche Diagnostics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-15
- Terminated
- 2020-04-23
- Firm location
- Indianapolis, IN, United States
510(k) clearances named in this recall
3 on FDA's record- K163569 — Elecsys CMV IgM
- K162606 — Elecsys TSH assay, cobas e 801 Immunoassay analyzer
- K100853 — COBAS 8000 MODULAR SERIES ANALYZER
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.