Z-1189-2024 Class III Ongoing
FDA device recall Z-1189-2024 was initiated by Abbott Molecular, Inc. on February 1, 2024 and is designated Class III. 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. The recall status is ongoing. Affected quantity: 7 kits.
Recall Details
- Product Type
- Devices
- Report Date
- March 6, 2024
- Initiation Date
- February 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 kits
Product Description
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;
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 Pattern
US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
Code Information
(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.