# FDA recall Z-0812-2020

> **Microbiologics Inc** · Class II · device recall initiated 2019-12-16.

## Product

Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180  Used in test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

## Reason for recall

The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet), has changed from sterile 0.85% saline or sterile blood culture media to sterile DI water or pH 7.2 phosphate buffer.

## Distribution

Distributed nationwide including Washington DC, and distributed internationally to Germany and Netherlands.

## Key facts

- **Recall number:** Z-0812-2020
- **Recalling firm:** Microbiologics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-16
- **Report date:** 2020-01-22
- **Termination date:** 2020-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Cloud, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0812-2020

## Citation

> AI Analytics. FDA recall Z-0812-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0812-2020. Source: US FDA. Licensed CC0.

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