Z-1415-2023Class II

BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall...

Name: Z-1415-2023 BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall...
Creator: Becton Dickinson & Co.
Published: 2023-03-22
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2023-03-22 / Open, Classified / root cause: software

FDA source

Becton Dickinson & Co. began a recall of 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... on 2023-03-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1415-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-22
Posted: 2023-04-20
Recalling firm: Becton Dickinson & Co
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
Product code: JTC Device, Microtiter Diluting/Dispensing
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.
Root cause tag: software
FDA root cause: Software design
Action: 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: [email protected]
Quantity in commerce: 7 instruments
Distribution: Worldwide - US Nationwide distribution in the states of IL, NY and the countries of Netherlands, Saudi Arabia.
Product codes and lots: UDI: 038290LSUVLPKFPV Serial Numbers: INO-000156, INO-000249, INO-000248, INO-000252, INO-000254, 20130276, 19033ST002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1415-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1415-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-20

Product code JTC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)