# FDA recall Z-2598-2018

> **Becton, Dickinson and Company, BD Biosciences** · Class III · device recall initiated 2018-05-16.

## Product

BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only.  The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA.     The Loader offers various settings to resuspend and mix samples. It can draw from 12 x 75-mm tubes in 30- and 40-tube racks. A barcode reader verifies the ID on tube racks and individual tubes in 30- tube racks. A built-in imaging system provides safety checks, such as verifying the correct rack type and tube layout, and ensures the tubes were loaded correctly.

## Reason for recall

The solenoid plunger tip length is too short  resulting in insufficient engagement to the Universal Loader enclosure to lock during use.

## Distribution

US Distribution was made to FL, KS, KY, MA, NJ, and SD.

## Key facts

- **Recall number:** Z-2598-2018
- **Recalling firm:** Becton, Dickinson and Company, BD Biosciences
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-16
- **Report date:** 2018-08-08
- **Termination date:** 2018-08-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2598-2018

## Citation

> AI Analytics. FDA recall Z-2598-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2598-2018. Source: US FDA. Licensed CC0.

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