Recall Z-1089-2017— The Binding Site Group, Ltd.
Class III · Terminated
Class III FDA medical device recall by The Binding Site Group, Ltd., initiated 2016-12-23, terminated 2017-05-03. It names one FDA 510(k) clearance: K150526. Product: Optilite IgG4 Kit Product Code: LK009.OPT.A. Reason: A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert.
- Recalling firm
- The Binding Site Group, Ltd.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-12-23
- Terminated
- 2017-05-03
- Firm location
- Birmingham, N/A, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Optilite IgG4 Kit Product Code: LK009.OPT.A
Reason for recall
A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert
Data sourced from openFDA. This site is unofficial and independent of the FDA.