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U.S. Department of Health and Human Services

Class 2 Device Recall Randox CRP test system

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 Class 2 Device Recall Randox CRP test systemsee related information
Date Initiated by FirmFebruary 01, 2023
Date PostedSeptember 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1286-2023
Recall Event ID 91745
510(K)NumberK953212 
Product Classification C-reactive protein, antigen, antiserum, and control - Product Code DCK
ProductCRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
Code Information GTIN: 05055273201765 Batch: 588434
FEI Number 3003059701
Recalling Firm/
Manufacturer		 Randox Laboratories
515 Industrial Blvd
Kearneysville WV 25430-2778
Manufacturer Reason
for Recall		The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range
FDA Determined
Cause 2		Under Investigation by firm
ActionRandox UK (manufacturer) extended Urgent Medical Device Removal letter to the US distributor via email on 2/1/23. The distributor contacted the customer via email on 2/6/23. Letter states reason for recall, health risk and action to take: " Discontinue use of and discard any of the above immediately. Provide Randox with photographic evidence of the destruction of the kits. " Review your reagent inventory of these products and assess your laboratories needs for reimbursement for discarded inventory. " Review results generated with the affected batches in line with the clinical profile of the patient. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. If you have any questions or concerns, please contact Randox Technical Services.
Quantity in Commerce2 kits
DistributionPA, OH, WV
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 = DCK
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