FDA Device recall Z-1074-2019
CELL-DYN Emerald analyzer, REF 09H39-01
- FDA Device
- Class II
- terminated
- Published 2019-04-10
On 2019-04-10 the FDA classified a Class II recall of CELL-DYN Emerald analyzer, REF 09H39-01 by Abbott Laboratories, citing there is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1074-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-02-20 |
| Published | 2019-04-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
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
There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.
Identifiers
| code_info | All serial numbers below 7765. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1074-2019%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.