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U.S. Department of Health and Human Services

Class 2 Device Recall CReactive Protein Kit for use on the SPAplus

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  Class 2 Device Recall CReactive Protein Kit for use on the SPAplus see related information
Date Initiated by Firm April 25, 2019
Date Posted March 31, 2020
Recall Status1 Terminated 3 on April 27, 2021
Recall Number Z-1619-2020
Recall Event ID 84890
510(K)Number K161982  
Product Classification System, test, c-reactive protein - Product Code DCN
Product C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
Code Information Lot 455672
Recalling Firm/
Manufacturer		 The Binding Site Group, Ltd.
8 Calthorpe Road
Birmingham United Kingdom
Manufacturer Reason
for Recall		 A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 4/25/2019, a Customer Notice was issued by the firm's UK office to firm's US office. The US office was instructed to provide this information to the end customer within 24 hours of receiving the notification along with a form to fill out and return. The Customer Notice issued to the affected customer advises immediate quarantine and disposal of affected kits following local regulations. Customers were asked to pass on the customer notice and to all those who need to be aware within their organization or to any organization where potentially affected devices have been transferred. The customer notice requests the customer to complete, sign and return the e-back form. This confirms receipt of the Customer Notice, the number of kits disposed of and that the advice has been followed, along with a witness signature. Firm requests that e-back form be returned to Technical.support@bindingsite.com or to a local firm representative within one week. Should you require additional information, contact your local representative or Technical Support Group at UK: +44(0) 1214569696.
Quantity in Commerce 1 kit
Distribution U.S.: FL
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = DCN and Original Applicant = THE BINDING SITE GROUP
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