Z-2438-2019Class II

BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202

Name: Z-2438-2019 BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
Creator: Becton Dickinson & Co.
Published: 2019-07-26
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-07-26 / Terminated / root cause: software

FDA source

Becton Dickinson & Co. began a recall of BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202 on 2019-07-26. FDA classified it as Class II and gives the reason as "An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2438-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-26
Posted: 2019-08-30
Terminated: 2019-12-06
Recalling firm: Becton Dickinson & Co
Product: BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
Product code: JTC Device, Microtiter Diluting/Dispensing
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
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 4 units
Distribution: Illinois, Iowa, Missouri, New York, Ohio, Tennessee World Wide (5): Singapore, Taiwan, France, Netherlands
Product codes and lots: Catalog Number: 447202 Catalog Number/UDI INO-000287 00382904472023 INO-000286 00382904472023 INO-000269 00382904472023 INO-000281 00382904472023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2438-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2438-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-08-30
Z-2439-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-08-30

Product code JTC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)