FDA Medical Device Recalls (openFDA)
Remel Europe Ltd.: 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.
- Recall number
- Z-2920-2020
- Recalling firm
- Remel Europe Ltd.
- 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.
- Status
- Terminated
- Initiated
- 2020-07-23
- Posted
- not on file
- Terminated
- 2022-03-22
- Reason
- 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
- Root cause
- Under Investigation by firm
- Action
- On July 23, 2020, Thermo Scientific issued a Medical Device field action recall on behalf of the Foreign Manufacturer of the affected product, Remel Europe Ltd . The notification states the following action to be taken: 1. The firm requests that you destroy any remaining inventory of the lot listed and contact Technical Services regarding any necessary replacements. 2. Requirement for review of reported test results should be determined by the appropriate technical expert. 3. Please keep this notification on file. 4. Complete the accompanying Acknowledgment Form upon receipt and return to MBD.vigilance@thermofisher.com. If you have any questions, please contact Technical Services Department at 800-255-6730 (US) or email microbiology.ts.us@thermofisher.com.
- Quantity
- 79 units
- 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.
- Lot, serial or model codes
- Lot # 2407976
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GOY
- Firm FEI
- 3003750284
- Firm city
- Dartford
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28