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U.S. Department of Health and Human Services

Class 2 Device Recall Human IgM Kit for use on SPAPLUS

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  Class 2 Device Recall Human IgM Kit for use on SPAPLUS see related information
Date Initiated by Firm July 25, 2018
Date Posted November 17, 2018
Recall Status1 Terminated 3 on April 27, 2021
Recall Number Z-0477-2019
Recall Event ID 81409
510(K)Number K082129  
Product Classification Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
Product Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S

The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.
Code Information Lot: 407483-1 and 407483-2
Recalling Firm/
Manufacturer		 The Binding Site Group, Ltd.
8 Calthorpe Road
Birmingham United Kingdom
Manufacturer Reason
for Recall		 After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control results may be out of range one day after running the assay calibration curve. Samples have been shown to be similarly affected.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 07/25/2018, the Urgent Field Safety Notice and Field Correction E-back Form were emailed to customers. Customers were advised to cease use of the affected product and to dispose of the kits locally. This notice states that a witness signature of kit disposal is required on the E-back form. This notice needs to be passed on to all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been transferred. Customers with additional questions are encouraged to contact their local firm representative, or customer service via phone at +44(0) 1214569696, or email at Technical.support@bindingsite.co.uk. The E-back Form requests that each customer and witness sign and date confirming they have both received and have followed the advice issued in the Notification. It also asks for the number of product in stock and number of kits disposed.
Quantity in Commerce 108
Distribution U.S.: IL, WV, NE, SD, NY, IN, WA, MD, NJ, PA, NC, AR, FL, VA
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 = CFN and Original Applicant = THE BINDING SITE, LTD.
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