Hologic, Inc: Medical Device Recall in 2017 - (Recall #: Z-0027-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 15, 2017

Date Posted: October 25, 2017

Recall Number: Z-0027-2018

Event ID: 78216

Reason for Recall:

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

Status: Terminated

Product Quantity: 1 unit

Code Information:

Serial Number 20900001124

Distribution Pattern:

Indiana

Voluntary or Mandated:

Voluntary: Firm initiated