Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53… — Class II medical device recall Z-2576-2021
Terminated recall by Abbott Molecular, Inc., reported 2021-10-06, distributed nationwide. Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.
| Recall number | Z-2576-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Molecular, Inc., Des Plaines, IL, United States |
| Recall initiated | 2021-08-04 |
| Classified | 2021-09-27 |
| Reported by FDA | 2021-10-06 |
| Terminated | 2023-05-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, CN, CR, CZ, DE, EE, ES, GB, HK, IL, IT, KR, NL, PH, PL, SA, SI, UY, ZA |
| Quantity | 186 units |
| UPC / GTIN / UDI-DI | 00884999042780 |
| Lot numbers | 04N02-021, 04N02-022, 05J83-001/PART, 32-191025, 517086, 518656 |
| Model numbers | 04N02-021, 04N02-022, 05J83-001, 32-191025 |
Product
Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, SpectrumAqua/CEP 12 SpectrumGreen Probes
Reason for recall
Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.
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-2576-2021. 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.