Recall Z-2192-2020— Abbott Diagnostics Technologies AS

Name: FDA recall Z-2192-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-23

Class II · Ongoing

Class II FDA medical device recall by Abbott Diagnostics Technologies AS, initiated 2020-03-23. It names 2 FDA 510(k) clearances: K182988, K180296. Product: 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.. Reason: 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..

Recalling firm: Abbott Diagnostics Technologies AS
Classification: Class II
Status: Ongoing
Initiated: 2020-03-23
Firm location: Oslo, N/A, Norway

510(k) clearances named in this recall

2 on FDA's record

K182988 — Afinion HbA1c Dx on Afinion 2Alere Technologies AS·cleared 2018-11-29
K180296 — Afinion HbA1c DxAlere Technologies AS·cleared 2018-05-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.