# FDA recall Z-2576-2021

> **Abbott Molecular, Inc.** · Class II · device recall initiated 2021-08-04.

## Product

Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, SpectrumAqua/CEP 12 SpectrumGreen Probes

## Reason for recall

Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MI, MN, MA, NC, NJ, NM, NY, OH, PA, TN, TX, UT, VA, VT, WA, WI and the countries of  Australia, Belgium, Brazil, Canada, China, Costa Rica, Czech Republic, Estonia, Germany, Hong Kong, Israel, Italy, Kazakhstan, Netherlands, Philippines, Poland, Saudi Arabia, Slovenia, South Africa, South Korea, Spain, United Kingdom, Uruguay.

## Key facts

- **Recall number:** Z-2576-2021
- **Recalling firm:** Abbott Molecular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-04
- **Report date:** 2021-10-06
- **Termination date:** 2023-05-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Des Plaines, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2576-2021

## Citation

> AI Analytics. FDA recall Z-2576-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2576-2021. Source: US FDA. Licensed CC0.

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