Recall Z-1055-2017 ยท JZQ Plates And Equipment, Radial Immunodiffusion
The Binding Site Group, Ltd.
Digital RID Plate Reader and Software Product Code: AD400
| Date | Jan 19, 2017 (initiated Oct 9, 2012) |
| Status | Terminated |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.