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
Check against the official notice below — it lists the full affected range.
Abbott Molecular, Inc. recalled 186 units of Vysis CLL FISH Probe Kits used to detect genetic changes in chronic lymphocytic leukemia samples. The kits had the potential to fail to detect 13q deletions in patient samples that actually contained these deletions, which could result in missed diagnoses. The affected kits were distributed worldwide, including across numerous U.S. states and international countries, with specific lot numbers and part numbers identified in the recall notice.
The recall record does not specify a remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.
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, Quantity: 186 units Lot/code info: UDI: (01)00884999042780(10)XXXXX(17)211015(240)04N02-021; US Distribution: Part Number 04N02-021, Lot Numbers 517086, 518656; International Distribution: List/Part Numbers (Lot Number): 04N02-021 (517086, 518656), 04N02-022 (517516, 519303), 05J83-001/Part 32-191025 (517068).
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.