Abbott Molecular, Inc.: 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 Te

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: 7 kits Lot/code info: (1) REF 01N33-020 - GTIN 00884999000759, Lot #381411, Exp. 2024-09-22; (2) REF 04N62-020 - GTIN 00884999009301, Lot #382133, Exp. 2024-05-25; (3) REF 05J03-001 - GTIN 00884999009882, Lot #381111, Exp. 2024-06-17; (4) REF 05J03-004 - GTIN 00884999009912, Lot #381102, Exp. 2024-06-17; (5) REF 05J04-022 - GTIN 00884999010451, Lot #530242, Exp. 2024-03-28.

UPC codes

00884999000759, 00884999009301, 00884999009882, 00884999009912, 00884999010451

Source

Official record: FDA (Device enforcement) ↗

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