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.
|