Abbott Molecular, Inc.: 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;

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.

Details from the source

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. Quantity: 16 kits Lot/code info: (1) REF 01N15-010 - GTIN 00884999035362, Lot #381146, Exp. 2024-05-05; #381870, Exp. 2024-05-05; #382179 Exp. 2024-05-05; #387021, Exp. 2024-08-01; #528081, exp. 2023-11-16; (2) REF 01N34-020 - GTIN 00884999000766, Lot #522756, Exp. 2023-06-21.

UPC codes

00884999035362, 00884999000766

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.