Device recall
Z-1415-2023: BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and…
FDA device recall · Class II · Becton Dickinson & Co.
Key facts
| Recall number (Z-number) | Z-1415-2023 |
|---|---|
| Recall event | 91937 |
| Product | BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform. An in vitro diagnostic medical device intended to automate specimen processing according to user-defined procedures and protocols. Catalog (Ref) No. : 447213 |
| Product code | JTC |
| Recalling firm | Becton Dickinson & Co. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1119779 |
At a glance
- None 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