| Class 2 Device Recall Vysis CLL FISH Probe Kit | |
Date Initiated by Firm | August 04, 2021 |
Create Date | September 27, 2021 |
Recall Status1 |
Terminated 3 on May 31, 2023 |
Recall Number | Z-2576-2021 |
Recall Event ID |
88565 |
Product Classification |
Chronic lymphocytic leukemia fish probe kit - Product Code OVQ
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Product | 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 |
Code Information |
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). |
Recalling Firm/ Manufacturer |
Abbott Molecular, Inc. 1300 E Touhy Ave Des Plaines IL 60018-3315
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For Additional Information Contact | 224-361-7619 |
Manufacturer Reason for Recall | Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | 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. |
Quantity in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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