Z-0027-2018Class II

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

Name: Z-0027-2018 Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Creator: Hologic, Inc
Published: 2017-09-15
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2017-09-15 / Terminated / root cause: manufacturing process

FDA source

Hologic, Inc began a recall of Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use on 2017-09-15. FDA classified it as Class II and gives the reason as "An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0027-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-15
Posted: 2017-10-18
Terminated: 2020-07-30
Recalling firm: Hologic, Inc.
Product: Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Product code: NSU Instrumentation For Clinical Multiplex Test Systems
Reason for recall: An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The customer was notifed of the potential incorrect results via a phone call on September 15, 2017. A customer letter was sent on September 18, 2017. The notification letter requests the customer to re-test any negative Aptima Combo 2 assay results tested between July 13, 2017 Aug 30, 2017.
Quantity in commerce: 1 unit
Distribution: Indiana
Product codes and lots: Serial Number 20900001124

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0027-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0027-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-25	2017-10-18

Product code NSU

K132251Class IIAptima Combo 2 Assay (Panther System)Hologic / Gen-Probe Incorporated / cleared 2013-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)