Z-1055-2017Class II

Digital RID Plate Reader and Software

Name: Z-1055-2017 Digital RID Plate Reader and Software
Creator: The Binding Site Group, Ltd.
Published: 2012-10-09
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2012-10-09 / Terminated / root cause: software

FDA source

The Binding Site Group, Ltd. began a recall of Digital RID Plate Reader and Software Product Code: AD400 on 2012-10-09. FDA classified it as Class II and gives the reason as "If a control ring is marked after reading, the software will not flag results that are out of the specified QC range". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1055-2017
Classification: Class II
Status: Terminated
Initiated: 2012-10-09
Posted: 2017-01-19
Terminated: 2017-04-04
Recalling firm: The Binding Site Group Ltd.
Product: Digital RID Plate Reader and Software Product Code: AD400
Product code: JZQ Plates And Equipment, Radial Immunodiffusion
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.
Root cause tag: software
FDA 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: [email protected].
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.
Product codes and lots: UDI 05051700000376

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1055-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1055-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-19

Product code JZQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)