BD Kiestra InoqulA Software Version 20 — Class II medical device recall Z-2438-2019
Terminated recall by Becton Dickinson & Co., reported 2019-09-11, distributed in IA, IL, MO, NY, OH, TN. An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch betwe
| Recall number | Z-2438-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2019-07-26 |
| Classified | 2019-08-30 |
| Reported by FDA | 2019-09-11 |
| Terminated | 2019-12-06 |
| Distributed | IA, IL, MO, NY, OH, TN |
| Countries outside the US | FR, NL, SG, TW |
| Quantity | 4 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00382904472023 |
| Model numbers | 447202 |
Product
BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
Reason for recall
An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2438-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.