Device product
BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
Z-2438-2019
Product summary
- Event
- Event 83513
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-2438-2019
Official wording
Reason: An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate
Code information: Catalog Number: 447202 Catalog Number/UDI INO-000287 00382904472023 INO-000286 00382904472023 INO-000269 00382904472023 INO-000281 00382904472023
Distribution pattern: Illinois, Iowa, Missouri, New York, Ohio, Tennessee World Wide (5): Singapore, Taiwan, France, Netherlands
Derived failure modes
-
Device software or design
anomaly is present in InoqulA / InoqulA+ software