FDA recall Z-0027-2018

Product

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

Reason for recall

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

Distribution

Indiana

Key facts

Status

Terminated

Initiation date

2017-09-15

Report date

2017-10-25

Termination date

2020-07-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0027-2018