Drug recall
CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is…
FDA recall event 73655 · Class II · Abbott Laboratories
Key facts
| Event ID | 73655 |
|---|---|
| Recall numbers | Z-1522-2016 |
| Recalling firm | Abbott Laboratories |
| Product type | Devices |
| Products | CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality Control Out of Range Low for parameters RBC and PLT. |
| Initiation date | Mar 24, 2016 |
| Report date | Apr 27, 2016 |
| Termination date | Jan 4, 2017 |
| City | Santa Clara |
| State | CA |
| Country | United States |
| FEI number | 2919069 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: