Recall Z-2439-2019 ยท JTC Device, Microtiter Diluting/Dispensing
Becton Dickinson & Co.
BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213
| Date | Jul 26, 2019 |
| Status | Terminated |
| Reason | 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 | 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 S |
| Quantity | 9 units |
| Distribution | Illinois, Iowa, Missouri, New York, Ohio, Tennessee World Wide (5): Singapore, Taiwan, France, Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.