Recall Z-0027-2018— Hologic, Inc

Name: FDA recall Z-0027-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-15

Class II · Terminated

Class II FDA medical device recall by Hologic, Inc, initiated 2017-09-15, terminated 2020-07-30. It names one FDA 510(k) clearance: K132251. Product: Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use. Reason: An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results..

Recalling firm: Hologic, Inc
Classification: Class II
Status: Terminated
Initiated: 2017-09-15
Terminated: 2020-07-30
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K132251 — APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)Hologic / Gen-Probe Incorporated·cleared 2013-10-17

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

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.

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