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.
Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.
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.
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.
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.
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).
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.
No, the recall does not require immediate stop use. However, affected kits should be checked for the specific part numbers and lot codes.
Contact Abbott directly for instructions on how to handle the kit. The recall does not specify a return or replacement process.
The recall is for potential false negative results in cancer testing, not a direct safety hazard. Patients should follow their healthcare provider's guidance.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-2576-2021 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-2576-2021 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
