Aquarius LPH 511-A CRLF2 Distal Probe Green — Class II medical device recall Z-1099-2021
Terminated recall by Cytocell Ltd., reported 2021-02-17, distributed in CA, IL, MI, MN, NJ, TX, WA. Users may observe very faint additional locus specific signals at 11q13. There is a low risk of a normal sampl
| Recall number | Z-1099-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cytocell Ltd., Cambridge, N/A, United Kingdom |
| Recall initiated | 2020-12-22 |
| Classified | 2021-02-08 |
| Reported by FDA | 2021-02-17 |
| Terminated | 2022-06-07 |
| Distributed | CA, IL, MI, MN, NJ, TX, WA |
| Countries outside the US | CA |
| Quantity | 72 |
| Lot numbers | 071390, 072240, 072693 |
| Model numbers | 511-A, CRLF2 |
Product
Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric) to the CRLF2 gene
Reason for recall
Users may observe very faint additional locus specific signals at 11q13. There is a low risk of a normal sample being reported as not normal in a resulting laboratory developed test (LDT) that utilizes the LPH511-A CRLF2 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-1099-2021. 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.