# FDA recall Z-0290-2018

> **Remel Inc** · Class II · device recall initiated 2017-12-08.

## Product

Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01.      Product Usage:  Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes.

## Reason for recall

The serum may fail to agglutinate within the specified minimum reaction time.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0290-2018
- **Recalling firm:** Remel Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-08
- **Report date:** 2018-01-03
- **Termination date:** 2020-07-22

- **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-0290-2018

## Citation

> AI Analytics. FDA recall Z-0290-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0290-2018. Source: US FDA. Licensed CC0.

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