Device recall
Z-2322-2015: Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included…
FDA device recall · Class III · Acon Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-2322-2015 |
|---|---|
| Recall event | 71550 |
| Product | Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at… |
| Product code | DJZ |
| Recalling firm | Acon Laboratories, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 8, 2015 |
| 510(k) numbers | K093143 |
| FEI number | 3003516723 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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