FDA Device recall Z-1188-2024
In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010
- FDA Device
- Class III
- ongoing
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class III recall of In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010 by Abbott Molecular, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1188-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-02-01 |
| Published | 2024-03-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abbott Molecular |
| Distribution | US |
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;
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.
Identifiers
| code_info | (1) REF 01N15-010 - GTIN 00884999035362, Lot #381146, Exp. 2024-05-05; #381870, Exp. 2024-05-05; #382179 Exp. 2024-05-0…(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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1188-2024%22
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