International safety notice
Urgent Field Safety Notice for Elecsys Anti-CCP (Modular Analytics E170, cobas e411, cobas e 601, cobas e 602, 100 tests) 05031656190. Lots: 368033, 376804, 389152, Elecsys Anti-CCP (cobas e 801, 100 tests) 072 by Roche Diagnostics GmbH
Germany / BfArM · DEU · Jul 24, 2019
Key facts
| Title | Urgent Field Safety Notice for Elecsys Anti-CCP (Modular Analytics E170, cobas e411, cobas e 601, cobas e 602, 100 tests) 05031656190. Lots: 368033, 376804, 389152, Elecsys Anti-CCP (cobas e 801, 100 tests) 072 by Roche Diagnostics GmbH |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | Elecsys Anti-CCP (Modular Analytics E170, cobas e411, cobas e 601, cobas e 602, 100 tests) 05031656190. Lots: 368033, 376804, 389152, Elecsys Anti-CCP (cobas e 801, 100 tests) 072 |
| Manufacturer | Roche Diagnostics GmbH |
| Models | 389152, SBN-CPS-2019-012, 389165, 400794, 07251670190, 05031656160, FSN-CPS-2019-012, 368037, 388800, 368033, 368029, 376808 and 6 more |
| Date | Jul 24, 2019 |
| Regulator page | bfarm.de |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1