# FDA recall Z-2920-2020

> **Remel Europe Ltd.** · Class II · device recall initiated 2020-07-23.

## Product

Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordetella antisera are suitable for use in slide agglutination tests to serologically identify Bordetella pertussis and Bordetella parapertussis for epidemiological and diagnostic purposes.

## Reason for recall

Thermo Scientific" Remel" Bordetella pertussis Agglutinating Serum (R30165501/ZM10) is not performing, resulting in the potential for false negative results for serotypes 1 and 3

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of MO, CA and the countries of CA, AT, BO, CN, CZ, GB, GM, HK, IE, IT, MX, MY, NL,OM, SA.

## Key facts

- **Recall number:** Z-2920-2020
- **Recalling firm:** Remel Europe Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-23
- **Report date:** 2020-09-09
- **Termination date:** 2022-03-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dartford, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2920-2020

## Citation

> AI Analytics. FDA recall Z-2920-2020. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-2920-2020. Source: US FDA. Licensed CC0.

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