FDA Device recall Z-0604-2024
Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01
- FDA Device
- Class II
- ongoing
- Published 2023-12-27
On 2023-12-27 the FDA classified a Class II recall of Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01 by Abbott Laboratories, citing the devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0604-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-19 |
| Published | 2023-12-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Laboratories |
| Distribution | 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 |
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
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Identifiers
| code_info | All serial numbers are involved. CELL-DYN Ruby - UDI/DI 00380740017170; CELL-DYN Sapphire - UDI/DI 00380740016616. |
|---|
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-0604-2024%22
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