# FDA recall Z-1369-2021

> **Hologic, Inc** · Class II · device recall initiated 2021-02-26.

## Product

Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.

## Reason for recall

There is a potential for tube trays to leak  which could potentially result in false positive results, false negative results or invalid patient results.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CT, DC, FL, GA, HI, IL, IN, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NY, OH, OR, PA, TX, UT, VA, VT, WA, WI, WV and the countries of Austria (AT), Belgium (BE), France (FR), Germany (DE), Great Britain (GB), Italy (IT) Netherlands (NL), Spain (ES), Switzerland (CH),, Canada (CA), Hong Kong (HK), Australia (AU), New Zealand (NZ).

## Key facts

- **Recall number:** Z-1369-2021
- **Recalling firm:** Hologic, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-02-26
- **Report date:** 2021-04-14

- **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-1369-2021

## Citation

> AI Analytics. FDA recall Z-1369-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1369-2021. Source: US FDA. Licensed CC0.

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