Recall Z-2136-2018— Roche Diagnostics Corporation
Class II · Terminated
Class II FDA medical device recall by Roche Diagnostics Corporation, initiated 2018-04-03, terminated 2019-11-21. It names 3 FDA 510(k) clearances: K163569, K162606, K100853. Product: cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.. Reason: The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function..
- Recalling firm
- Roche Diagnostics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-03
- Terminated
- 2019-11-21
- 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, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.
Reason for recall
The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function.
Data sourced from openFDA. This site is unofficial and independent of the FDA.