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
Reported: October 6, 2021 Initiated: August 4, 2021 #Z-2576-2021
Product Description
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.
Details
- Recalling Firm
- Abbott Molecular, Inc.
- Units Affected
- 186 units
- 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.
- Location
- Des Plaines, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Abbott Molecular, Inc.. Units affected: 186 units.
Why was this product recalled? ▼
Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 6, 2021. Severity: Moderate. Recall number: Z-2576-2021.
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