Device recall
Z-0429-2013: Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels…
FDA device recall · Class III · Horiba Instruments, Inc dba Horiba Medical
Key facts
| Recall number (Z-number) | Z-0429-2013 |
|---|---|
| Recall event | 63539 |
| Product | Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). Minotrol 16 is a tri-level control intended for in vitro diagnostic use in monitoring the accuracy and precision on HORIBA Medical hematology blood cell counters using HORIBA Medical reagents… |
| Product code | JPK |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 22, 2013 |
| 510(k) numbers | K843962, K850755 |
| FEI number | 3002698356 |
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