Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog… — Class II medical device recall Z-1655-2025
Ongoing recall by Abbott Laboratories, reported 2025-04-30, distributed nationwide. When expired reagents are scanned or manually entered, the system will change the expiration date to current o
| Recall number | Z-1655-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Abbott Park, IL, United States |
| Recall initiated | 2025-03-18 |
| Classified | 2025-04-22 |
| Reported by FDA | 2025-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BB, BD, BE, BG, BH, BO, BR, BS, BZ, CA, CL, CN, CO, CZ, DE, DZ, EC, EG, ES, FR, GB, GR, GT, HN, HR, HT, HU, ID, IE, IL, IN, IR, IT, JM, JO, JP, KE, KW, KY, LB, LK, LT, LU, MA, MT, MX, MY, NG, NI, NO, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, UY, VN, ZA |
| Quantity | 1 |
| UPC / GTIN / UDI-DI | 00380740017170 |
| Model numbers | 08H67-13 |
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 for recall
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.
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-1655-2025. 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.