Hologic recalls Panther System (Catalog 902615) for potential incorrect test results due to an incorrect incubator installation. Affected units have serial number 20900001124.
An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
Hologic is recalling its Panther System (Catalog Number 902:15) because an incorrect incubator installation could lead to wrong test results for Aptima Combo 2 assays. This affects diagnostic testing accuracy and requires verification of the system's configuration.
The recall is triggered by an incorrect incubator installation on the Panther System. This error can cause the Aptima Combo 2 assay results to be inaccurate, potentially leading to incorrect medical decisions.
Users of the Panther System for in vitro diagnostic testing, particularly those using Aptima Combo 2 assays. Laboratories and healthcare facilities that have the specific catalog number are most at risk.
Check for the Panther System with catalog number 902615 and serial number 20900001124. The system is used for in vitro diagnostic purposes with Hologic assays.
Confirm the incubator is correctly installed to ensure accurate Aptima Combo 2 assay results.
An incorrect incubator installation on the Panther System could lead to inaccurate Aptima Combo 2 assay results.
Check if your Panther System has the catalog number 902615 and serial number 20900001124. Verify the incubator installation for accurate results.
The recall does not mention a specific fix or replacement; users should verify their system configuration.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-0027-2018 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-0027-2018 from Hologic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
