Recall Z-1089-2017 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
The Binding Site Group, Ltd.
Optilite IgG4 Kit Product Code: LK009.OPT.A
| Date | Dec 23, 2016 |
| Status | Terminated |
| 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 |
| Root cause | Under Investigation by 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 n |
| Quantity | 9 users |
| Distribution | U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150526 | Optilite IgG4 Kit The Binding Site Group , Ltd., May 30, 2015 |