BD Kiestra InoqulA+ recallZ-2438-2019 · Becton Dickinson & Co. · initiated Jul 26, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson & Co. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate
FDA root cause category: Software design
What the company is doing
BD initiated a field correction via letter on July 26, 2019 and BD Technical Service has completed the correction (software upgrade) for all six (6) affected US customers. Letter identifies issue, health risk and customer action to take. BD is in the process of evaluating the log files of customers using the InoqulATM / InoqulA+TM software version 20.3 to determine if any users potentially experienced mismatch between a specimen and plate. BD will contact all customers using InoqulATM / InoqulA+TM software version 20.3 to provide the outcome of this evaluation. Contact: BD Customer/Technical Support 800-638-8663 Monday Friday between 7:00am and 7:00pm (EST) in the United States. For customers outside the US, contact your local BD representative or distributor.
Recall details
- Recall number
- Z-2438-2019
- Status
- Terminated
- Initiated by the company
- Jul 26, 2019
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 4 units
- Product code
- JTC
- Distribution
- Illinois, Iowa, Missouri, New York, Ohio, Tennessee World Wide (5): Singapore, Taiwan, France, Netherlands
Product description
BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
Code information (models, lots, serial numbers)
Catalog Number: 447202 Catalog Number/UDI INO-000287 00382904472023 INO-000286 00382904472023 INO-000269 00382904472023 INO-000281 00382904472023
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BD Kiestra™ InoqulA+™ 447202BD Kiestra B.V. · DEVICE, MICROTITER DILUTING/DISPENSING1 recall30 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 83513).
- Z-2439-2019 · TerminatedBD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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