# FDA recall Z-1320-2018

> **Mindray DS USA, Inc. dba Mindray North America** · Class II · device recall initiated 2018-01-24.

## Product

Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-005405-00 (2 x 5.5L container), (2) 105-005406-00 (20L container)      The M-30D Diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-3200 and BC-3600 Hematology Analyzer.

## Reason for recall

Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzers may cause the system to produce an elevated platelet background count.

## Distribution

US Distribution including Puerto Rico and to the states of :  CA,  MI, NC, TX, and WA. .

## Key facts

- **Recall number:** Z-1320-2018
- **Recalling firm:** Mindray DS USA, Inc. dba Mindray North America
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-24
- **Report date:** 2018-04-18
- **Termination date:** 2019-04-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1320-2018

## Citation

> AI Analytics. FDA recall Z-1320-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1320-2018. Source: US FDA. Licensed CC0.

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