International safety notice
Urgent Field Safety Notice for COBAS INTEGRA® 400 plus analyzer with ISE, model number: 03245233001 COBAS INTEGRA ® 400 plus analyzer w/o (without) ISE, model number: 04922859001 by Roche Diagnostics GmbH
Germany / BfArM · DEU · Jul 17, 2019
Key facts
| Title | Urgent Field Safety Notice for COBAS INTEGRA® 400 plus analyzer with ISE, model number: 03245233001 COBAS INTEGRA ® 400 plus analyzer w/o (without) ISE, model number: 04922859001 by Roche Diagnostics GmbH |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | COBAS INTEGRA® 400 plus analyzer with ISE, model number: 03245233001 COBAS INTEGRA ® 400 plus analyzer w/o (without) ISE, model number: 04922859001 |
| Manufacturer | Roche Diagnostics GmbH |
| Models | 520002, 410893, 3.6.1, 420002, 520005, 401749, 520008, 03245233001, 520001, SBN-CPS-2018-015, 04922859001, 520006 and 8 more |
| Date | Jul 17, 2019 |
| Regulator page | bfarm.de |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers 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