Z-2438-2019 Class II Terminated

Recalled by Becton Dickinson & Co. — Sparks, MD

Recall Details

Product Type
Devices
Report Date
September 11, 2019
Initiation Date
July 26, 2019
Termination Date
December 6, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 units

Product Description

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

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 Pattern

Illinois, Iowa, Missouri, New York, Ohio, Tennessee World Wide (5): Singapore, Taiwan, France, Netherlands

Code Information

Catalog Number: 447202 Catalog Number/UDI INO-000287 00382904472023 INO-000286 00382904472023 INO-000269 00382904472023 INO-000281 00382904472023