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U.S. Department of Health and Human Services

Class 2 Device Recall BD Kiestra" InoqulA"

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 Class 2 Device Recall BD Kiestra" InoqulA"see related information
Date Initiated by FirmMarch 22, 2023
Date PostedApril 20, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1415-2023
Recall Event ID 91937
Product Classification Device, microtiter diluting/dispensing - Product Code JTC
ProductBD 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
Code Information UDI: 038290LSUVLPKFPV Serial Numbers: INO-000156, INO-000249, INO-000248, INO-000252, INO-000254, 20130276, 19033ST002
FEI Number 1119779
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information ContactSAME
410-316-4000
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionBD 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
Quantity in Commerce7 instruments
DistributionWorldwide - US Nationwide distribution in the states of IL, NY and the countries of Netherlands, Saudi Arabia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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