Drug recall
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and…
FDA recall event 92586 · Class II · Cytocell Ltd.
Key facts
| Event ID | 92586 |
|---|---|
| Recall numbers | Z-2209-2023, Z-2210-2023 |
| Recalling firm | Cytocell Ltd. |
| Product type | Devices |
| Products | RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome., RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. |
| Initiation date | May 24, 2023 |
| Report date | Jul 26, 2023 |
| City | Cambridge |
| Country | United Kingdom |
| FEI number | 3002646096 |
At a glance
- 1–9 Products in this recall
- None 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: