# FDA recall Z-0027-2018

> **Hologic, Inc** · Class II · device recall initiated 2017-09-15.

## Product

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.

## Distribution

Indiana

## Key facts

- **Recall number:** Z-0027-2018
- **Recalling firm:** Hologic, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-15
- **Report date:** 2017-10-25
- **Termination date:** 2020-07-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0027-2018

## Citation

> AI Analytics. FDA recall Z-0027-2018. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0027-2018. Source: US FDA. Licensed CC0.

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