Z-2576-2021Class II

Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and...

Name: Z-2576-2021 Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and...
Creator: Abbott Molecular, Inc.
Published: 2021-08-04
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2021-08-04 / Terminated

FDA source

Abbott Molecular, Inc. began a recall of Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34... on 2021-08-04. FDA classified it as Class II and gives the reason as "Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2576-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-04
Posted: 2021-09-27
Terminated: 2023-05-31
Recalling firm: Abbott Molecular, Inc.
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
Product code: OVQ Chronic Lymphocytic Leukemia Fish Probe Kit
Reason for recall: Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.
FDA root cause: 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.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2576-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2576-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-27

Product code OVQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)