Device recall
Z-0630-2016: arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX…
FDA device recall · Class I · Arkray Factory USA, Inc.
Key facts
| Recall number (Z-number) | Z-0630-2016 |
|---|---|
| Recall event | 72860 |
| Product | arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples. |
| Product code | CGA |
| Recalling firm | Arkray Factory USA, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jan 4, 2017 |
| 510(k) numbers | K041427 |
| FEI number | 1832816 |
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