FDA Device recall Z-1099-2021
Aquarius LPH 511-A CRLF2 Distal Probe Green, model no
- FDA Device
- Class II
- terminated
- Published 2021-02-17
On 2021-02-17 the FDA classified a Class II recall of Aquarius LPH 511-A CRLF2 Distal Probe Green, model no by Cytocell, citing 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 te….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1099-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-22 |
| Published | 2021-02-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cytocell |
| Distribution | CA, IL, MI, MN, NJ, TX, WA |
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
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.
Identifiers
| code_info | Lots 072240, 071390, and 072693 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1099-2021%22
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