FDA-Device2024-03-06Class III
In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;
Abbott Molecular, Inc.
Hazard
Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
Sold states
US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
Affected count
16 kits
Manufactured in
1300 E Touhy Ave, Des Plaines, IL, United States
Products
In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1188-2024Don't want to check this manually?
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