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Abbott Molecular, Inc. recalls In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319
Recalled March 6, 2024 · FDA recall Z-1188-2024 · 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
16 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 MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;
Manufacturer(s)
Abbott Molecular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →