Recall Z-1415-2023 ยท JTC Device, Microtiter Diluting/Dispensing
Becton Dickinson & Co.
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
| Date | Apr 20, 2023 (initiated Mar 22, 2023) |
| Status | Open, Classified |
| 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 envi |
| 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 notif |
| Quantity | 7 instruments |
| Distribution | Worldwide - US Nationwide distribution in the states of IL, NY and the countries of Netherlands, Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.