Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501 Recalled by Remel Europe Ltd. Due to Thermo Scientific" Remel" Bordetella pertussis Agglutinating Serum (R30165501/ZM10)...

Date: July 23, 2020
Company: Remel Europe Ltd.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Remel Europe Ltd. directly.

Affected Products

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.

Quantity: 79 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Remel Europe Ltd.

Remel Europe Ltd. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report