International safety notice
Analizador Afinion 2 Ref: 1116553, 1116556, 1116557, 1116597, 1116598, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, Analizador Alere Afinion AS100 Ref: 1116049,1116050, 1116053, 1116054,1116456, 1116980
Spain / AEMPS · ESP · May 5, 2020
Key facts
| Title | Analizador Afinion 2 Ref: 1116553, 1116556, 1116557, 1116597, 1116598, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, Analizador Alere Afinion AS100 Ref: 1116049,1116050, 1116053, 1116054,1116456, 1116980 |
|---|---|
| Regulator | Spain / AEMPS |
| Country | ESP |
| Brand | Analizador Afinion 2 Ref: 1116553, 1116556, 1116557, 1116597, 1116598, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, Analizador Alere Afinion AS100 Ref: 1116049,1116050, 1116053, 1116054,1116456, 1116980 |
| Manufacturer | Abbott Diagnostics Technologies AS, Noruega |
| Models | 1116456, FSCA-00002386, 91.822.52.89, 1116556, 1116679, AFINION™2, 1116050, 13485, 1116684, 1116778, 58716, 1116680 and 23 more |
| Event type | Safety Notice |
| Date | May 5, 2020 |
At a glance
- No Recall
- Yes Field safety notice
- 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