Abbott Vysis CLL FISH Probe Kit Recall: May Miss 13q Deletions in Cancer Testing
Abbott recalls Vysis CLL FISH Probe Kits that may not detect 13q deletions in cancer samples. Affected kits have specific part numbers and lot codes. Contact Abbott for details.
Lower-risk recall
Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.
Contact the company
What happened, in plain English
Abbott is recalling Vysis CLL FISH Probe Kits that might not detect 13q deletions in cancer patient samples. This could lead to incorrect test results if the kit is used without the recall fix. Read more at govinfonow.com/recall/62085-abbott-vysis-cll-fish-probe-kit-recall-may-miss-13q.
Source Summary by GovInfoNow · govinfonow.com/recall/62085-abbott-vysis-cll-fish-probe-kit-recall-may-miss-13q · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2576-2021
Cite this page
“Abbott Vysis CLL FISH Probe Kit Recall: May Miss 13q Deletions in Cancer Testing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62085-abbott-vysis-cll-fish-probe-kit-recall-may-miss-13q. Based on FDA recall #Z-2576-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2576-2021%22&limit=1).
Why it’s dangerous
The kits may fail to detect 13q deletions in known positive patient samples. This could cause false negative results in cancer testing, potentially missing critical genetic markers.
Who’s affected
Healthcare professionals using the Vysis CLL FISH Probe Kit for cancer testing are most at risk. Patients receiving these tests may have inaccurate results if the kit is not recalled.
How to tell if you have this one
Check for part number 04N02-021 with lot numbers 517086 or 518656 in the US. International kits may have part numbers 04N02-021 (lots 517086, 518656) or 04N02-022 (lots 517516, 519303).
- Brand
Abbott- Product
Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI- Category
Medical device
What to do — step by step
Check Kit Details
Look for part number 04N02-021 with lot numbers 517086 or 518656 in the US, or part numbers 04N02-021/04N02-022 with specific lot codes internationally.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 23 states.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, New Jersey, New Mexico, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using this kit?
No, the recall does not require immediate stop use. However, affected kits should be checked for the specific part numbers and lot codes.
Is this recall dangerous for patients?
The recall is for potential false negative results in cancer testing, not a direct safety hazard. Patients should follow their healthcare provider's guidance.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2576-2021 (August 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2576-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.