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U.S. Department of Health and Human Services

Class 2 Device Recall BioPlex 2200 AntiCCP Kit

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 Class 2 Device Recall BioPlex 2200 AntiCCP Kitsee related information
Date Initiated by FirmFebruary 21, 2023
Date PostedApril 12, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1378-2023
Recall Event ID 91854
510(K)NumberK093954 K112810 
Product Classification Antibodies, anti-cyclic citrullinated peptide (ccp) - Product Code NHX
ProductBioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
Code Information Lot # 53727; UDI GTIN: 00847865000819
FEI Number 3008272466
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories, Inc.
6565 185th Ave Ne
Redmond WA 98052-5039
For Additional Information ContactMs. Anna Gralinska-schram
510-741-6643
Manufacturer Reason
for Recall		Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8  96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1  98.8%). The reduction in specificity may lead to an increase in the number of false positivesBio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8  96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1  98.8%). The reduction in specificity may lead to an increase in the number of false positivesBio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8  96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1  98.8%). The reduction in specificity may lead to an increase in the number of false positives.There is no performance issue with the calibrator lot# 53727. They are included in the recall only because the calibrators are lot matched to the impacted reagent pack.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn February 21, 2023, Bio-Rad Laboratories issued a "Urgent: Medical Device Recall" notification to affected consignees. In addition to informing consignees about the recall, Bio-Rad asked consignees to take the following actions: 1. We are requesting that customers discontinue the use of and dispose of according to local waste management procedures any unused BioPlex 2200 Anti-CCP Reagent Pack (Catalog No. 665-3250, UDI GTIN 00847865000857) Lot No. 301481 and BioPlex 2200 Anti-CCPCalibrator Set (Catalog No. 663-3200, UDI GTIN 00847865000819) Lot No. 53727. 2. If you have distributed or transferred this product to any other Bio-Rad customers, or to any other laboratories from your site, please notify those customers of this field action. 3. Please complete the attached Customer Response Form and return it to your local Bio-Rad Technical Support so they can assist you with obtaining replacement reagent packs and calibrator sets Bio-Rad is working to provide a new lot of BioPlex 2200 Anti-CCP Reagent Pack and matching calibrator sets as soon as possible. Please provide the number of replacement units required in the attached customer response form.
Quantity in Commerce225 units
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, Norway, Sweden.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NHX
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