Device recall
Z-0937-2014: Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation…
FDA device recall · Class II · ITC-Nexus Dx
Key facts
| Recall number (Z-number) | Z-0937-2014 |
|---|---|
| Recall event | 67237 |
| Product | 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 low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin… |
| Product code | GFO |
| Recalling firm | ITC-Nexus Dx |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 30, 2014 |
| 510(k) numbers | K014008 |
| FEI number | 2250033 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database