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U.S. Department of Health and Human Services

Class 2 Device Recall Thermo Scientific Remel Bordetella pertussis

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 Class 2 Device Recall Thermo Scientific Remel Bordetella pertussissee related information
Date Initiated by FirmJuly 23, 2020
Create DateAugust 28, 2020
Recall Status1 Terminated 3 on March 22, 2022
Recall NumberZ-2920-2020
Recall Event ID 86109
Product Classification Antisera, agglutinating, b. Pertussis, all - Product Code GOY
ProductThermo 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.
Code Information Lot # 2407976
FEI Number 3003750284
Recalling Firm/
Manufacturer		 Remel Europe Ltd.
Clipper Boulevard West
Dartford United Kingdom
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionOn 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 in Commerce79 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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