Recall Z-1415-2023— Becton Dickinson & Co.

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2023-03-22. FDA's recall record names no specific 510(k) clearance for this event. Product: BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform. An in vitro diagnostic medical device intended to automate specimen processing according to user-defined procedures and protocols. Catalog (Ref) No. : 447213. Reason: Upon installation of BD Kiestra" InoqulA+" and BeA version 5.1 and 5.1.1 as part of the Icefall A platform, plate information was not visible in Synapsys" after processing has occurred. This could possibly lead to a delayed diagnosis and/or treatment or need for specimen recollection streaking plated media, and inoculating tubes and slides. In Semi-Automated (SA) mode, plates are automatically selected, barcoded, streaked in a pre-configured pattern while the user manually inoculates plates, tubes, and slides. An optional biosafety cabinet on the SA module provides personnel, product, and environmental protection. The InoqulA+" solution is indicated for use in the clinical laboratory..

Recalling firm

Becton Dickinson & Co.

Classification

Class II

Status

Ongoing

Initiated

2023-03-22

Firm location

Sparks, MD, United States

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