Abbott Diagnostics Technologies AS Recalls

Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.

Class I - Dangerous

Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.

Jun 17, 2024 Infusion Pumps Nationwide View Details →

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.

Class I - Dangerous

The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional.

Mar 23, 2020 Diagnostic Equipment View Details →