# FDA recall Z-1415-2023

> **Becton Dickinson & Co.** · Class II · device recall initiated 2023-03-22.

## 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

## 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.

## Distribution

Worldwide - US Nationwide distribution in the states of IL, NY and the countries of  Netherlands, Saudi Arabia.

## Key facts

- **Recall number:** Z-1415-2023
- **Recalling firm:** Becton Dickinson & Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-22
- **Report date:** 2023-04-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sparks, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1415-2023

## Citation

> AI Analytics. FDA recall Z-1415-2023. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1415-2023. Source: US FDA. Licensed CC0.

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