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
- Company
- Abbott Molecular, Inc.
- Recall Initiated
- August 4, 2021
- Terminated
- May 31, 2023
- Recall Number
- Z-2576-2021
- Quantity
- 186 units
- Firm Location
- Des Plaines, IL
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.
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).
Root Cause
Under Investigation by firm
Action Taken
On about 08/04/2021, Abbott Molecular notified consignees via FedEx with letter titled "Urgent Field Safety Notice Molecular Diagnostics at Abbott Product: Vysis CLL FISH Probe." The letter instructed customers to discontinue use of the affected lots, discard any remaining kits on hand, complete and return the customer reply form, and notify impacted customers if the affected lots have been further distributed. Additional instructions included to review the recall notification information with your Medical Director or physicians as appropriate and retain the communication for future reference. Review patient results generated with the impacted lots and determine if retesting is required taking patient medical history and previous treatment into consideration.