CELL-DYN Emerald analyzer — Class II medical device recall Z-1074-2019
Terminated recall by Abbott Laboratories, reported 2019-04-10, distributed nationwide. There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RB
| Recall number | Z-1074-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Santa Clara, CA, United States |
| Recall initiated | 2019-02-20 |
| Classified | 2019-03-29 |
| Reported by FDA | 2019-04-10 |
| Terminated | 2021-08-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BB, BD, BE, BG, BH, BM, BR, BS, BZ, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DO, EC, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HT, HU, ID, IE, IL, IN, IQ, IR, IT, JM, JO, KE, KR, KW, LB, LK, LT, LU, LV, MX, MY, NG, NL, NO, NZ, OM, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SG, SI, SK, SV, TH, TR, TT, TW, UY, VE, VN, ZA |
| Quantity | 6,353 units |
| Model numbers | 09H39-01 |
Product
CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.
Reason for recall
There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.
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-1074-2019. 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.