FDA recall Z-2438-2019

Product

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

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

Key facts

Status

Terminated

Initiation date

2019-07-26

Report date

2019-09-11

Termination date

2019-12-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sparks, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2438-2019