FDA Medical Device Recalls (openFDA)
The Binding Site Group, Ltd.: Digital RID Plate Reader and Software Product Code: AD400
- Recall number
- Z-1055-2017
- Recalling firm
- The Binding Site Group, Ltd.
- Product
- Digital RID Plate Reader and Software Product Code: AD400
- Status
- Terminated
- Initiated
- 2012-10-09
- Posted
- 2017-01-19
- Terminated
- 2017-04-04
- Reason
- If a control ring is marked after reading, the software will not flag results that are out of the specified QC range.
- Root cause
- Software Design Change
- Action
- 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.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- UDI 05051700000376
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JZQ
- Firm FEI
- 3002808340
- Firm city
- Birmingham
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28