Class III

Medical Device Recall: 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. · February 1, 2024

Reason for Recall

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.

Distribution

US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.

States Affected

NATIONWIDE

Quantity Affected

16 kits

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1188-2024

Status: ongoing

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