Drug recall
Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in…
FDA recall event 67237 · Class II · ITC-Nexus Dx
Key facts
| Event ID | 67237 |
|---|---|
| Recall numbers | Z-0937-2014 |
| Recalling firm | ITC-Nexus Dx |
| Product type | Devices |
| Products | Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals. |
| Initiation date | Dec 19, 2013 |
| Report date | Feb 12, 2014 |
| Termination date | Oct 30, 2014 |
| City | Edison |
| State | NJ |
| Country | United States |
| FEI number | 2250033 |
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: