Drug recall
pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1…
FDA recall event 65722 · Class II · Sysmex America Inc
Key facts
| Event ID | 65722 |
|---|---|
| Recall numbers | Z-0100-2014 |
| Recalling firm | Sysmex America Inc |
| Product type | Devices |
| Products | pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number. |
| Initiation date | May 15, 2013 |
| Report date | Nov 6, 2013 |
| Termination date | Aug 15, 2016 |
| City | Lincolnshire |
| State | IL |
| Country | United States |
| FEI number | 3009711478 |
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: