Z-2576-2021 Class II Terminated
FDA device recall Z-2576-2021 was initiated by Abbott Molecular, Inc. on August 4, 2021 and is designated Class II. Reason for recall: Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples. The recall status is terminated (terminated May 31, 2023). Affected quantity: 186 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 6, 2021
- Initiation Date
- August 4, 2021
- Termination Date
- May 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 186 units
Product Description
Reason for Recall
Distribution Pattern
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.