Device recall
Z-1171-2016: Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro…
FDA device recall · Class II · Sekisui Diagnostics P.E.I. Inc.
Key facts
| Recall number (Z-number) | Z-1171-2016 |
|---|---|
| Recall event | 73129 |
| Product | Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of… |
| Product code | LDP |
| Recalling firm | Sekisui Diagnostics P.E.I. Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 9, 2016 |
| 510(k) numbers | K081938 |
| FEI number | 3002806809 |
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