Abbott Diagnostics Technologies AS
Abbott Diagnostics Technologies AS holds FDA 510(k) medical device clearance, cleared in 2023, with 2 FDA device recalls on record.
Top product codes for Abbott Diagnostics Technologies AS
FDA recalls by Abbott Diagnostics Technologies AS
- Z-2736-2024 — Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
- Z-2192-2020 — Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970, 1116971, 1116985, 1116986, IVD. The firm name on the label is Abbott Diagnostics Technologies AS, Oslo, Norway. Power supply provided with Alere Afinion AS100 Analyzer, Catalog numbers 1115175, 1115390, 1116049, 1116050, 1116053, 1116054, 1116456, and 1116980. The firm name on the label is Alere Technologies AS, Oslo, Norway.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Abbott Diagnostics Technologies AS
Data sourced from openFDA. This site is unofficial and independent of the FDA.