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
- Company
- Becton Dickinson & Co.
- Recall Initiated
- March 22, 2023
- Posted
- April 20, 2023
- Recall Number
- Z-1415-2023
- Quantity
- 7 instruments
- Firm Location
- Sparks, MD
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.
Distribution
Worldwide - US Nationwide distribution in the states of IL, NY and the countries of Netherlands, Saudi Arabia.
Lot / Code Info
UDI: 038290LSUVLPKFPV Serial Numbers: INO-000156, INO-000249, INO-000248, INO-000252, INO-000254, 20130276, 19033ST002
Root Cause
Software design
Action Taken
BD issued URGENT: Medical Device Product Correction on 3/22/23 via email. Letter states reason for recall,, health risk and action to take: 1) Read and understand the content of this letter. 2) Share and post this recall letter within your facility network to ensure awareness. 3) Customers should utilize the module of the Icefall platform identified by their regional BD service team that does not exhibit this issue to avoid possible unavailability of results. 4) Complete the attached Customer Response Form and return to the BD contact noted so that BD may acknowledge your receipt of this notification per FDA requirements. Taken by BD: 1) BD has developed and remotely implemented an interim solution to immediately address the software issue and prevent disruption of testing for the patients. 2) BD is taking further action to prevent recurrence of this product issue. Contact Information: US Contact Information Areas of Support North American Regional Complaint Center, Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted. Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com