Z-1188-2024 Class III Ongoing
FDA device recall Z-1188-2024 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: 16 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
- 16 kits
Product Description
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;
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 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.