FDA Device recall Z-1358-2023
Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
- FDA Device
- Class III
- ongoing
- Published 2023-04-19
On 2023-04-19 the FDA classified a Class III recall of Agilent Resolution ctDx FIRST Sample Collection Kit, 500032 by Agilent Technologies Us, citing distributed sample collection kit with an unapproved instruction for use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1358-2023 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2023-02-17 |
| Published | 2023-04-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Agilent Technologies Us |
| Distribution | US |
Product
Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
Reason
Distributed sample collection kit with an unapproved instruction for use.
Identifiers
| code_info | Model/Part Number: 50032 UDI Code: N/A, single site PMA Lot Numbers: 23-0139 23-0140 23-0142 23-0143 23-0159 |
|---|
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-1358-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.