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Terminated

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

FDA Recall Z-0027-2018 · Posted None

Recalling FirmHologic, Inc
Recall StatusTerminated
Product CodeNSU
Date Initiated2017-09-15
Date Terminated2020-07-30
Product Quantity1 unit

Reason for Recall

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

Firm 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.

Root Cause

Employee error

Distribution Pattern

Indiana

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K132251APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)Hologic / Gen-Probe Incorporated · 2013-10-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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