Hologic, Inc recalls Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

Recalled October 25, 2017 · FDA recall Z-0027-2018 · Hologic

Hazard

An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results. · FDA Class II

Units

1 unit

Sold at

Indiana

Description

An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.

Product

Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

Manufacturer(s)

Hologic, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →