Recall Z-1055-2017— The Binding Site Group, Ltd.
Class II · Terminated
Class II FDA medical device recall by The Binding Site Group, Ltd., initiated 2012-10-09, terminated 2017-04-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Digital RID Plate Reader and Software Product Code: AD400. Reason: If a control ring is marked after reading, the software will not flag results that are out of the specified QC range..
- Recalling firm
- The Binding Site Group, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-10-09
- Terminated
- 2017-04-04
- Firm location
- Birmingham, United Kingdom
Product description
Digital RID Plate Reader and Software Product Code: AD400
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.