FDA Device recall Z-2438-2019
BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
- FDA Device
- Class II
- terminated
- Published 2019-09-11
On 2019-09-11 the FDA classified a Class II recall of BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202 by Becton Dickinson And, citing an anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2438-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-26 |
| Published | 2019-09-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Becton Dickinson And |
| Distribution | IA, IL, MO, NY, OH, TN |
Product
BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
Reason
An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate
Identifiers
| code_info | Catalog Number: 447202 Catalog Number/UDI INO-000287 00382904472023 INO-000286 00382904472023 INO-000269 00382904472023 INO-000281 00382904472023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2438-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.