# FDA recall Z-2990-2020

> **Hologic, Inc** · Class II · device recall initiated 2020-08-04.

## Product

Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000

## Reason for recall

Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay.

## Distribution

U.S. :ID, SC, VT, CA, IL, UT, NJ, MA, TX, AL, CO, FL, ME, NY, VA, WA, WI, OR, DC, GA, NC, HI, CT, OK, TN,    O.U.S.: CA, SE, GB, DE, DO, IT, ES, NO, BE, NL, FR, DK, AT

## Key facts

- **Recall number:** Z-2990-2020
- **Recalling firm:** Hologic, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-04
- **Report date:** 2020-09-30
- **Termination date:** 2024-12-23

- **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-2990-2020

## Citation

> AI Analytics. FDA recall Z-2990-2020. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-2990-2020. Source: US FDA. Licensed CC0.

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