Z-1188-2024 Class III Ongoing
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.