FDA Device recall Z-2209-2023
RET Proximal Probe
- FDA Device
- Class II
- ongoing
- Published 2023-07-26
On 2023-07-26 the FDA classified a Class II recall of RET Proximal Probe by Cytocell, citing DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2209-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-24 |
| Published | 2023-07-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cytocell |
| Distribution | US |
Product
RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Reason
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
Identifiers
| code_info | Catalog No. LPS508-A; UDI-DI: 05055844900509; Lot No. 076763, 077253, 080125, 080763, 082128, 083041, 083246, 083555. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2209-2023%22
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