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Class 2 Device Recall BioPlex 2200 AntiCCP Kit |
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Date Initiated by Firm |
February 21, 2023 |
Date Posted |
April 12, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1377-2023 |
Recall Event ID |
91854 |
510(K)Number |
K112810 K093954
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Product Classification |
Antibodies, anti-cyclic citrullinated peptide (ccp) - Product Code NHX
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Product |
BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD |
Code Information |
Lot # 301481; UDI GTIN: 00847865000857 |
Recalling Firm/ Manufacturer |
Bio-Rad Laboratories, Inc. 6565 185th Ave Ne Redmond WA 98052-5039
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For Additional Information Contact |
Ms. Anna Gralinska-schram 510-741-6643
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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 positives.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
On 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 Commerce |
1544 units |
Distribution |
Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, Norway, Sweden.
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Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = NHX and Original Applicant = Bio-Rad Laboratories
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