PlainRecalls
FDA Devices Moderate Class II Terminated

BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213

Reported: September 11, 2019 Initiated: July 26, 2019 #Z-2439-2019

Product Description

BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213

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

Details

Recalling Firm
Becton Dickinson & Co.
Units Affected
9 units
Distribution
Illinois, Iowa, Missouri, New York, Ohio, Tennessee World Wide (5): Singapore, Taiwan, France, Netherlands
Location
Sparks, MD

Frequently Asked Questions

What product was recalled?
BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213. Recalled by Becton Dickinson & Co.. Units affected: 9 units.
Why was this product recalled?
An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate
Which agency issued this recall?
This recall was issued by the FDA Devices on September 11, 2019. Severity: Moderate. Recall number: Z-2439-2019.