Z-2920-2020Class II

Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI...

Name: Z-2920-2020 Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI...
Creator: Remel Europe Ltd.
Published: 2020-07-23
License: https://open.fda.gov/license/

Remel Europe Ltd. / initiated 2020-07-23 / Terminated

FDA source

Remel Europe Ltd. began a recall of Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordetella antisera are... on 2020-07-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2920-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-23
Posted: 2020-08-28
Terminated: 2022-03-22
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.
Product code: GOY Antisera, Agglutinating, B. Pertussis, All
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
FDA 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 [email protected]. If you have any questions, please contact Technical Services Department at 800-255-6730 (US) or email [email protected].
Quantity in commerce: 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.
Product codes and lots: Lot # 2407976

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2920-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2920-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-09	2020-08-28

Product code GOY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)