# FDA recall Z-0750-2022

> **Hologic, Inc** · Class II · device recall initiated 2022-01-27.

## Product

Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA

## Reason for recall

Failed stability specifications for reagent kits that may result in false negative test results.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AR, CA, CT, FL, GA, ID, IL, IN, MA, MD, ME, MI, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI, WV, District of Columbia and the countries of Canada, Australia, Belgium, Netherlands, China, Italy, Germany, Sweden.

## Key facts

- **Recall number:** Z-0750-2022
- **Recalling firm:** Hologic, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-01-27
- **Report date:** 2022-03-23

- **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-0750-2022

## Citation

> AI Analytics. FDA recall Z-0750-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0750-2022. Source: US FDA. Licensed CC0.

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