Becton Dickinson & Co.: Medical Device Recall in 2023 - (Recall #: Z-1415-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 22, 2023

Date Posted: April 26, 2023

Recall Number: Z-1415-2023

Event ID: 91937

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 7 instruments

Code Information:

UDI: 038290LSUVLPKFPV Serial Numbers: INO-000156, INO-000249, INO-000248, INO-000252, INO-000254, 20130276, 19033ST002

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of IL, NY and the countries of Netherlands, Saudi Arabia.

Voluntary or Mandated:

Voluntary: Firm initiated