Hologic Panther System Recall: Incorrect Incubator May Cause Wrong Test Results
Hologic recalls Panther System (Catalog 902615) for potential incorrect test results due to an incorrect incubator installation. Affected units have serial number 20900001124.
Lower-risk recall
An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/73014-hologic-panther-system-recall-incorrect-incubator-may-cause-wrong-test.
Source Summary by GovInfoNow · govinfonow.com/recall/73014-hologic-panther-system-recall-incorrect-incubator-may-cause-wrong-test · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0027-2018
Cite this page
“Hologic Panther System Recall: Incorrect Incubator May Cause Wrong Test Results.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/73014-hologic-panther-system-recall-incorrect-incubator-may-cause-wrong-test. Based on FDA recall #Z-0027-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0027-2018%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Hologic- Category
Medical device
What to do — step by step
Verify System Configuration
Confirm the incubator is correctly installed to ensure accurate Aptima Combo 2 assay results.
Where it went and when
Where it was distributed
Distributed in Indiana.
FDA distribution: “Indiana” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Indiana.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0027-2018 (September 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0027-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.