Drug recall
cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay…
FDA recall event 75186 · Class II · Roche Diagnostics Operations, Inc.
Key facts
| Event ID | 75186 |
|---|---|
| Recall numbers | Z-0094-2017, Z-0095-2017, Z-0096-2017, Z-0097-2017, Z-0098-2017, Z-0099-2017, Z-0100-2017, Z-0101-2017, Z-0102-2017, Z-0103-2017, Z-0104-2017, Z-0105-2017 and 5 more |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Product type | Devices |
| Products | cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary…, cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and…, cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer Product Usage: The VS II system is a stand-alone, computer-controlled…, cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated…, cobas p 312 Pre-Analytical System calculator/data processing module, for clinical use Product Usage: The cobas p471 system is an automatic centrifuge module for centrifuging primary sample tubes… and 12 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzer s sample rack tray. The cleaning procedure for the sample rack tray has been revised to…, Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to… |
| Initiation date | Jul 15, 2016 |
| Report date | Nov 2, 2016 |
| Termination date | Jun 5, 2017 |
| City | Indianapolis |
| State | IN |
| Country | United States |
| FEI number | 1823260 |
At a glance
- 10–99 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: