Optilite IgG4 Kit Product Code: LK009.OPT.A
This recall has been terminated (originally issued December 23, 2016).
- Company
- The Binding Site Group, Ltd.
- Recall Initiated
- December 23, 2016
- Terminated
- May 3, 2017
- Recall Number
- Z-1089-2017
- Quantity
- 9 users
- Firm Location
- Birmingham United Kingdom
- Official Source
- View on FDA website ↗
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
Distribution
U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution.
Lot / Code Info
Lot #401413
Root Cause
Under Investigation by firm
Action Taken
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.