CELL-DYN Ruby System: List Number: 08H6701 — Class II medical device recall Z-1438-2017
Terminated recall by Abbott Laboratories, reported 2017-03-15. The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail
| Recall number | Z-1438-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Santa Clara, CA, United States |
| Recall initiated | 2017-02-13 |
| Classified | 2017-03-09 |
| Reported by FDA | 2017-03-15 |
| Terminated | 2018-03-06 |
| Countries outside the US | AE, AF, AR, BG, BR, CL, DE, EG, GB, HU, ID, IN, IQ, JO, JP, KE, LB, LU, MX, NL, PH, RO, RU, SA, TR, VN |
| Quantity | 116 |
| Serial numbers | 70002BG, 70003BG, 70004BG, 70005BG, 70006BG, 70007BG, 70008BG, 70009BG, 70010BG, 70011BG, 70012BG, 70013BG, 70014BG, 70016BG, 70018BG, 70019BG, 70020BG, 70021BG, 70024BG, 70025BG, 70026BG, 70028BG, 70029BG, 70030BG, 70031BG and 91 more |
Product
CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories
Reason for recall
The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage
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-1438-2017. 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.