Kit Label: Anti-FITC-AP CISH Accessory Kit — Class III medical device recall Z-1384-2022
Ongoing recall by Agilent Technologies, Inc., reported 2022-07-20, distributed nationwide. Label provided for substrate vail contained incorrect expiration date.
| Recall number | Z-1384-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Agilent Technologies, Inc., Santa Clara, CA, United States |
| Recall initiated | 2022-05-20 |
| Classified | 2022-07-14 |
| Reported by FDA | 2022-07-20 |
| Distributed | Nationwide (US) |
| Quantity | 63 kits |
| Reason classes | labeling |
| Lot numbers | 06586309, 06586327, 06646626, 06646739 |
| Model numbers | K589911-2, K589911-21 |
Product
Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512
Reason for recall
Label provided for substrate vail contained incorrect expiration date.
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-1384-2022. 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.