Optilite IgG4 Kit Product Code: LK009.OPT.A
FDA Recall Z-1089-2017 · Posted None
Recalling FirmThe Binding Site Group, Ltd.
Recall StatusTerminated
Product CodeCFN
Date Initiated2016-12-23
Date Terminated2017-05-03
Product Quantity9 users
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
Firm Action
Customer notification letters were sent on 12/23/16.
The Binding Site recommends to continue testing on the kit as normal and refer to the measuring ranges and limit of quantification stated in the notice and as indicated in the amended insert (INS009.OPT.A, Version: 21st December 2016) provided with this notification.
The notice needs to be passed on to all those who need to be aware within the organization or to any Organization where the potentially affected devices have been transferred.
Return the completed E-Back Form to your local Binding Site Representative for records and note that The Binding Site intends to report this correction to the FDA recall coordinator.
If you have any questions contact Technical Services.
Root Cause
Under Investigation by firm
Distribution Pattern
U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.