Abbott Molecular, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2576-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 4, 2021

Date Posted: October 6, 2021

Recall Number: Z-2576-2021

Event ID: 88565

Reason for Recall:

Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.

Status: Terminated

Product Quantity: 186 units

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).

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.

Voluntary or Mandated:

Voluntary: Firm initiated