CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13 — Class II medical device recall Z-2134-2021
Terminated recall by Cytocell Ltd., reported 2021-08-04, distributed in CA, IL, MO, NY, PA, TX, UT. The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint add
| Recall number | Z-2134-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cytocell Ltd., Cambridge, N/A, United Kingdom |
| Recall initiated | 2021-05-17 |
| Classified | 2021-07-23 |
| Reported by FDA | 2021-08-04 |
| Terminated | 2022-08-15 |
| Distributed | CA, IL, MO, NY, PA, TX, UT |
| Countries outside the US | CA |
| Quantity | 50 |
| Lot numbers | 071399, 072985 |
| Model numbers | LPU004-A |
Product
CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
Reason for recall
The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13.
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-2134-2021. 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.