Recall Z-2438-2019— Becton Dickinson & Co.

Name: FDA recall Z-2438-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-26

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2019-07-26, terminated 2019-12-06. FDA's recall record names no specific 510(k) clearance for this event. Product: BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202. Reason: An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate.

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Terminated
Initiated: 2019-07-26
Terminated: 2019-12-06
Firm location: Sparks, MD, United States

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.