Becton Dickinson recalls BD Kiestra InoqulA+ software versions 5.1 and 5.1.1 for possible delayed diagnosis due to invisible plate information after processing.
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.
Becton Dickinson is recalling specific versions of their BD Kiestra InoqulA+ software and associated BeA software. This could lead to delayed diagnosis or treatment because plate information becomes invisible after processing, requiring retesting.
After processing, plate information becomes invisible in Synapsys software. This could cause delayed diagnosis or treatment, or require retesting specimens to avoid errors in lab results.
Laboratory users who have BD Kiestra InoqulA+ software versions 5.1 or 5.1.1 installed on their Icefall A platform. Those handling clinical specimens are most at risk of needing retesting.
Check for software versions 5.1 or 5.1.1 on BD Kiestra InoqulA+ with the Icefall A platform. Serial numbers include INO-000156, INO-000249, INO-000248, INO-000252, INO-000254, 20130276, 19033ST002.
Verify if your BD Kiestra InoqulA+ software is version 5.1 or 5.1.1 with the Icefall A platform.
The recall is for possible delayed diagnosis or treatment because plate information becomes invisible after processing, requiring retesting.
Check if your software version is 5.1 or 5.1.1 with the Icefall A platform. If so, contact Becton Dickinson for guidance.
The recall record does not mention a remedy or fix.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-1415-2023 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-1415-2023 from Becton Dickinson. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
