Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Digital RID Plate Reader

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Digital RID Plate Readersee related information
Date Initiated by FirmOctober 09, 2012
Date PostedJanuary 19, 2017
Recall Status1 Terminated 3 on April 04, 2017
Recall NumberZ-1055-2017
Recall Event ID 76043
Product Classification Plates and equipment, radial immunodiffusion - Product Code JZQ
ProductDigital RID Plate Reader and Software Product Code: AD400
Code Information UDI 05051700000376
FEI Number 3002808340
Recalling Firm/
Manufacturer		 The Binding Site Group, Ltd.
8 Calthorpe Road
Birmingham United Kingdom
For Additional Information ContactGermaine Schwider
858-4539177
Manufacturer Reason
for Recall		If a control ring is marked after reading, the software will not flag results that are out of the specified QC range.
FDA Determined
Cause 2		Software Design Change
ActionOn 10/2012 notification letter was sent to customers requesting they take the following actions: 1. If have not already installed software version Vl.0.3 then please continue to work with version V1.0.2 until the above issues are resolved. 2. If have already installed software version V1.0.3, when processing results always mark the controlprior to reading the ring. 3. If are uncertain about the validity of any assays you have performed using software version Vl.0.3 please review the controlresults obtained and compare them to the specified control range for the RID assay and; " If the control results are acceptable then your assay is valid and results will be unaffected. " If the control results are not acceptable your assay should be considered invalid and your patient results should be reviewed and repeated as appropriate. On 02/2013 a second notification was sent in which customers were informed the new software was released. Customers were asked to take the following actions; 1. Upon receipt install the new software and uninstall the previou version 2. Install following the onscreen instructions. The installation process has not changed from previous versions. The instruction guide received with the RID Plate reader is still the current version. 3. After receipt of the new software disc complete and return the Eback form to The Binding Site. For further assistance contact Technical Services at The Binding Site via the email address: technicalservices@bindingsite.co.uk.
DistributionU.S. distribution to the following; MA, GA, NY, IA, CA, IL, UT, NJ, NC, MD, MN. Foreign distribution to the following; UK, Germany, Spain, France.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-