Abbott CELL-DYN Ruby — Class II medical device recall Z-0604-2024
Ongoing recall by Abbott Laboratories, reported 2023-12-27, distributed in AL, AR, AZ, CA, CO, FL, GA, IA…. The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural
| Recall number | Z-0604-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Abbott Park, IL, United States |
| Recall initiated | 2023-10-19 |
| Classified | 2023-12-21 |
| Reported by FDA | 2023-12-27 |
| Distributed | AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
| Countries outside the US | BR |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00380740016616, 00380740017170 |
Product
Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.
Reason for recall
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
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-0604-2024. 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.