FDA Device recall Z-1655-2025
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Descri…
- FDA Device
- Class II
- ongoing
- Published 2025-04-30
On 2025-04-30 the FDA classified a Class II recall of Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Descri… by Abbott Laboratories, citing when expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1655-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-18 |
| Published | 2025-04-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
Product
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
Reason
When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Identifiers
| code_info | UDI-DI 00380740017170 SN: 34036BG96 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1655-2025%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.