Del — Class II medical device recall Z-0741-2022
Terminated recall by Cytocell Ltd., reported 2022-03-16, distributed nationwide. individual components have been labelled with incorrect colours. The red and green colours are opposite to tho
| Recall number | Z-0741-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cytocell Ltd., Cambridge, N/A, United Kingdom |
| Recall initiated | 2022-01-18 |
| Classified | 2022-03-09 |
| Reported by FDA | 2022-03-16 |
| Terminated | 2024-11-08 |
| Distributed | Nationwide (US) |
| Quantity | 19 kits |
| UPC / GTIN / UDI-DI | 05055844901551 |
| Lot numbers | 075711 |
| Model numbers | USA-LPH024 |
| Expiration dates | 2023-06-22 |
Product
Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024
Reason for recall
individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control probe labelled in red rather than green. The expected positive signal pattern in the case of 1x deleted 5q will be 1G2R instead of 1R2G, an incorrect result
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-0741-2022. 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.