Device product
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;
Z-1188-2024
Product summary
- Event
- Event 93902
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 16 kits
- Official record key
device-enforcement:Z-1188-2024
Official wording
Reason: 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.
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.
Distribution pattern: US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
Derived failure modes
-
Unknown
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.