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U.S. Department of Health and Human Services

Class 2 Device Recall Rheumatoid Factor (RF) Kit for use on SPAPLUS

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  Class 2 Device Recall Rheumatoid Factor (RF) Kit for use on SPAPLUS see related information
Date Initiated by Firm January 04, 2018
Create Date February 08, 2018
Recall Status1 Terminated 3 on June 09, 2020
Recall Number Z-0553-2018
Recall Event ID 78934
510(K)Number K160070  
Product Classification System, test, rheumatoid factor - Product Code DHR
Product Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A

Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings
Code Information Lot #416595, Exp. 31/03/2018; UDI #05051700018319
Recalling Firm/
Manufacturer		 The Binding Site Group, Ltd.
8 Calthorpe Road
Birmingham United Kingdom
For Additional Information Contact
858-453-9177
Manufacturer Reason
for Recall		 The low and high controls for the product are returning results above the assigned values.
FDA Determined
Cause 2		 Under Investigation by firm
Action Binding Site sent an Urgent Field Safety Notice dated December 22, 2017. Advise on action to be taken by the User: " The new QC values detailed below should be used for the remainder of the shelf life of this Rheumatoid Factor Kit for use on SPAPLUS. "Input the revised QC values into your SPAPLUS instrument "Sign and return the TSWS18 E-Back Form accompanying this notification within 5 business days "Refer to Section 9 of the Product Insert SIN282(.A) if QCs are out of range following reassignment. For further questions, please call (858) 453-9177.
Quantity in Commerce 49 kits to the U.S. office (32 kits further distributed)
Distribution US Distribution was made to CA. There was no foreign/military/government distribution.
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 = DHR and Original Applicant = THE BINDING SITE GROUP, LTD.
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