Agilent Resolution ctDx FIRST Sample Collection Kit — Class III medical device recall Z-1358-2023
Ongoing recall by AGILENT TECHNOLOGIES INC./US, reported 2023-04-19, distributed nationwide. Distributed sample collection kit with an unapproved instruction for use.
| Recall number | Z-1358-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AGILENT TECHNOLOGIES INC./US, Kirkland, WA, United States |
| Recall initiated | 2023-02-17 |
| Classified | 2023-04-11 |
| Reported by FDA | 2023-04-19 |
| Distributed | Nationwide (US) |
| Quantity | 560 kits |
| Reason classes | unapproved product |
| Lot numbers | 23-0139, 23-0140, 23-0142, 23-0143, 23-0159 |
| Model numbers | 50032 |
Product
Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
Reason for recall
Distributed sample collection kit with an unapproved instruction for use.
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-1358-2023. 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.