International safety notice
Urgent Field Safety Notice for 03R65-01: Alinity i Processing Module; 03R67-01: Alinity c Processing Module; 04S68-02: Level Sensor, Bulk Solution; 03R66-03: Accessory kit, Alinity i; 03R69-03/03R69-04: Accessory kit #2, Alinity c by Abbott GmbH & Co.KG
Germany / BfArM · DEU · Nov 12, 2019
Key facts
| Title | Urgent Field Safety Notice for 03R65-01: Alinity i Processing Module; 03R67-01: Alinity c Processing Module; 04S68-02: Level Sensor, Bulk Solution; 03R66-03: Accessory kit, Alinity i; 03R69-03/03R69-04: Accessory kit #2, Alinity c by Abbott GmbH & Co.KG |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | 03R65-01: Alinity i Processing Module; 03R67-01: Alinity c Processing Module; 04S68-02: Level Sensor, Bulk Solution; 03R66-03: Accessory kit, Alinity i; 03R69-03/03R69-04: Accessory kit #2, Alinity c |
| Manufacturer | Abbott GmbH & Co.KG |
| Models | 04S68‐03, 04S68‐02, FA16SEP2019, 1‐877‐4ABBOTT, 03R69‐03, 1‐800‐332‐1088, 65205, 03R69‐04, 03R66‐03, PI1031‐2019, 1‐800‐FDA‐0178 |
| Date | Nov 12, 2019 |
| Regulator page | bfarm.de |
At a glance
- No Recall
- No Field safety notice
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