Cytocell LPH533-A NUP98 Distal Probe Green — Class II medical device recall Z-2829-2020
Terminated recall by Cytocell Ltd., reported 2020-08-26, distributed nationwide. A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LP
| Recall number | Z-2829-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cytocell Ltd., Cambridge, N/A, United Kingdom |
| Recall initiated | 2020-07-17 |
| Classified | 2020-08-20 |
| Reported by FDA | 2020-08-26 |
| Terminated | 2020-09-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 62 units |
| Lot numbers | 069305, 069468, 069915, 070433 |
Product
Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes.
Reason for recall
A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green.
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-2829-2020. 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.