# FDA recall Z-0769-2021

> **Remel Inc** · Class II · device recall initiated 2020-12-10.

## Product

Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049

## Reason for recall

The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.

## Distribution

Distribution in United States -  AL, FL, GA, LA MS, NC, SC, TN

## Key facts

- **Recall number:** Z-0769-2021
- **Recalling firm:** Remel Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-10
- **Report date:** 2021-01-20
- **Termination date:** 2023-07-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lenexa, KS, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0769-2021

## Citation

> AI Analytics. FDA recall Z-0769-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0769-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*