Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
- Company
- Hologic, Inc
- Recall Initiated
- September 15, 2017
- Terminated
- July 30, 2020
- Recall Number
- Z-0027-2018
- Quantity
- 1 unit
- Firm Location
- San Diego, CA
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
Lot / Code Info
Serial Number 20900001124
Root Cause
Employee error
Action Taken
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.
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