Digital RID Plate Reader and Software Product Code: AD400

FDA device recall Z-1055-2017 · posted 2017-01-19 · Terminated

Recall details

Recalling firm

The Binding Site Group, Ltd.

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.

Action taken

On 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.

Root cause

Software Design Change

Status

Terminated

Product code

JZQ

Distribution

U.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.

Date initiated

2012-10-09

Date posted

2017-01-19

Date terminated

2017-04-04

Location

Birmingham, United Kingdom