RET Distal Probe — Class II medical device recall Z-2210-2023
Ongoing recall by Cytocell Ltd., reported 2023-07-26, distributed nationwide. DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
| Recall number | Z-2210-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cytocell Ltd., Cambridge, N/A, United Kingdom |
| Recall initiated | 2023-05-24 |
| Classified | 2023-07-20 |
| Reported by FDA | 2023-07-26 |
| Distributed | Nationwide (US) |
| Quantity | 61 units |
| UPC / GTIN / UDI-DI | 05055844900516 |
| Lot numbers | 076764, 080124, 082129, 082560, 083247, 083550, 083850 |
| Model numbers | LPS509-A |
Product
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Reason for recall
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
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-2210-2023. 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.