FDA Device recall Z-2323-2021
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
- FDA Device
- Class II
- terminated
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class II recall of Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's) by Cytocell, citing may show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2323-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-27 |
| Published | 2021-08-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cytocell |
| Distribution | US |
Product
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Reason
May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34
Identifiers
| code_info | Lots 073004 and 072518 (Probe lot 200918-006). |
|---|
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-2323-2021%22
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