In-vitro diagnostic kits: — Class III medical device recall Z-1188-2024
Ongoing recall by Abbott Molecular, Inc., reported 2024-03-06, distributed nationwide. Products that were intended for export only which were not approved or registered in accordance with U.S. spec
| Recall number | Z-1188-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Molecular, Inc., Des Plaines, IL, United States |
| Recall initiated | 2024-02-01 |
| Classified | 2024-02-26 |
| Reported by FDA | 2024-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 16 kits |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 00884999000766, 00884999035362 |
| Lot numbers | 381146, 381870, 382179, 387021, 522756, 528081 |
| Model numbers | 01N15-010, 01N34-020 |
| Expiration dates | 2023-06-21, 2023-11-16, 2024-05-05, 2024-08-01 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1188-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.