Device recall
Z-1523-2016: Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog…
FDA device recall · Class III · Biocare Medical, LLC
Key facts
| Recall number (Z-number) | Z-1523-2016 |
|---|---|
| Recall event | 73752 |
| Product | Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabbit IgG primary antibodies… |
| Product code | NJT |
| Recalling firm | Biocare Medical, LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 20, 2016 |
| FEI number | 3004140393 |
At a glance
- None 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