BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
Check against the official notice below — it lists the full affected range.
Becton Dickinson & Co. is recalling BD Kiestra InoqulA Software Version 20.3.IVD (Catalog Number 447202) because an anomaly in the software has the potential to cause a mismatch between a specimen and plate during automated specimen processing. Four units of this software were distributed across multiple locations, including Illinois, Iowa, Missouri, New York, Ohio, and Tennessee in the United States, as well as internationally in Singapore, Taiwan, France, and the Netherlands.
The recall affects four specific product lots identified by their catalog numbers and UDI codes: INO-000287, INO-000286, INO-000269, and INO-000281. The source document does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate
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 Distribution: Illinois, Iowa, Missouri, New York, Ohio, Tennessee World Wide (5): Singapore, Taiwan, France, Netherlands Quantity: 4 units Lot/code info: Catalog Number: 447202 Catalog Number/UDI INO-000287 00382904472023 INO-000286 00382904472023 INO-000269 00382904472023 INO-000281 00382904472023
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.