Drug recall
Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and…
FDA recall event 88565 · Class II · Abbott Molecular, Inc.
Key facts
| Event ID | 88565 |
|---|---|
| Recall numbers | Z-2576-2021 |
| Recalling firm | Abbott Molecular, Inc. |
| Product type | Devices |
| Products | 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples. |
| Initiation date | Aug 4, 2021 |
| Report date | Oct 6, 2021 |
| Termination date | May 31, 2023 |
| City | Des Plaines |
| State | IL |
| Country | United States |
| FEI number | 3005248192 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: