Cytocell LPH019-A E2A — Class II medical device recall Z-2323-2021
Terminated recall by Cytocell Ltd., reported 2021-08-25, distributed nationwide. May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional
| Recall number | Z-2323-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cytocell Ltd., Cambridge, N/A, United Kingdom |
| Recall initiated | 2021-05-27 |
| Classified | 2021-08-18 |
| Reported by FDA | 2021-08-25 |
| Terminated | 2022-05-09 |
| Distributed | Nationwide (US) |
| Quantity | 23 units |
| Lot numbers | 072518, 073004, 200918-006 |
Product
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Reason for recall
May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34
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-2323-2021. 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.