Lower risk Medical device recall · FDA · Published March 22, 2023

Becton Dickinson BD Kiestra InoqulA+ Software Recalls: Delayed Diagnosis Risk

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1415-2023Medical device Becton Dickinson ›

Lower-risk 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.

Take action

Contact the company

Recalling firmBecton Dickinson & Co.7 Loveton Cir · Sparks, MD 21152-9212

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/58684-becton-dickinson-bd-kiestra-inoqula-software-recalls-delayed-diagnosis-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/58684-becton-dickinson-bd-kiestra-inoqula-software-recalls-delayed-diagnosis-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1415-2023

Cite this page

“Becton Dickinson BD Kiestra InoqulA+ Software Recalls: Delayed Diagnosis Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58684-becton-dickinson-bd-kiestra-inoqula-software-recalls-delayed-diagnosis-risk. Based on FDA recall #Z-1415-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1415-2023%22&limit=1).

The FDA announced on March 22, 2023, that Becton Dickinson & Co. is recalling BD Kiestra InoqulA+ systems with specific software versions due to a hazard where plate information may not be visible after processing. This issue could lead to delayed diagnosis or treatment. The agency classified the recall as Class II.

How to tell if you have it

Brand: Becton Dickinson
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
Catalog (Ref) No.: 447213
UDI: 038290LSUVLPKFPV
Serial Numbers: INO-000156, INO-000249, INO-000248, INO-000252, INO-000254, 20130276, 19033ST002
Units affected: 7 instruments

The hazard

Upon installation of the specified software versions as part of the Icefall A platform, plate information was not visible in Synapsys after processing. This could possibly lead to a delayed diagnosis and/or treatment or need for specimen recollection streaking plated media, and inoculating tubes and slides.

Context

GovInfoNow's records show Becton Dickinson & Co. has 43 other recalls on record since 2017-06-01. Other recent recalls of similar products include BD Kiestra Isolate Suspension Cuvette Array (2025-10-23), BD BACTEC 9120 Blood Culture System (2025-09-23), and BD GasP: CO2 Pouch System (2026-04-07). Other recent recalls of similar products include Beckman Coulter DxC 700 AU (2026-01-30) and BD Kiestra ReadA Lab Automation (2026-02-06).

How to tell if you have this one

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.

Brand
Becton Dickinson
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify if your BD Kiestra InoqulA+ software is version 5.1 or 5.1.1 with the Icefall A platform.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 2 states.

FDA distribution: “Worldwide - US Nationwide distribution in the states of IL, NY and the countries of Netherlands, Saudi Arabia.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Illinois, New York.

Recall timeline

FDA published this recall 35 days after the firm started it.

Mar 22, 2023Firm started the recall
Apr 20, 2023FDA classified it Class II
Apr 26, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/58684-becton-dickinson-bd-kiestra-inoqula-software-recalls-delayed-diagnosis-risk">Becton Dickinson BD Kiestra InoqulA+ Software Recalls: Delayed Diagnosis Risk (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1415-2023 (March 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1415-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.