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Abbott Molecular, Inc. recalls In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PT
Recalled March 6, 2024 · FDA recall Z-1189-2024 · Abbott Molecular
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. · FDA Class III
Units
7 kits
Sold at
US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
Description
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.
Product
In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020; (3) Abbott Vysis TelVysion 1p SpectrumGreen Probe, REF 05J03-001; (4) Abbott Vysis TelVysion 4P SpectrumGreen Probe, REF 05J03-004; (5) Abbott Vysis TelVysion 22q SpectrumOrange Probe, REF 05J04-022;
Manufacturer(s)
Abbott Molecular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →