FDA Device Recall Z-0027-2018: Hologic, Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0027-2018.

Recall Res Number

Z-0027-2018

Recalling Firm / Manufacturer

Hologic, Inc

FEI Number

2024800

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2017-09-15

Date Posted

N/A

Date Terminated

2020-07-30

Product Code

NSU

Event Number

78216

Product Quantity

1 unit

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.

Action Details 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.

Distribution Pattern Indiana

Code Information / Serial Numbers Serial Number 20900001124

Related Establishments / Registrations

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LRE MEDICAL GMBH Registration: 3003366417 View Registration
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PLEXUS CORP. Registration: 3004105270 View Registration
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STRATEC Switzerland AG Registration: 3008494306 View Registration
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DIESSE DIAGNOSTICA SENESE S.P.A Registration: 9615056 View Registration

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Medical Device Recall: Z-0027-2018

Recall Parameters & Description

Related Establishments / Registrations

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