# FDA recall Z-0562-2021

> **Becton, Dickinson and Company, BD Biosciences** · Class II · device recall initiated 2020-10-05.

## Product

BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.

## Reason for recall

Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AL, CA, CO, CT, DE, FL, GA, IL, IN, KY, MA, MD, MI, NC, NJ, NV, NY, OH, OK, PA, PR, RI, SD, TN, TX, and VA. The countries of Canada, Belgium, Korea, India, Ecuador, Japan, Costa Rica, Australia, Vietnam, Pakistan, Singapore, Thailand, and Peru.

## Key facts

- **Recall number:** Z-0562-2021
- **Recalling firm:** Becton, Dickinson and Company, BD Biosciences
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-05
- **Report date:** 2020-12-16
- **Termination date:** 2022-03-11

- **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-0562-2021

## Citation

> AI Analytics. FDA recall Z-0562-2021. Retrieved 2026-08-20 from https://api.ai-analytics.org/recall/Z-0562-2021. Source: US FDA. Licensed CC0.

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