Recall Z-1053-2017 ยท DEH Lambda, Antigen, Antiserum, Control
The Binding Site Group, Ltd.
Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases
| Date | Jan 19, 2017 (initiated Oct 28, 2016) |
| Status | Terminated |
| Reason | A change in the calibration curve causing an increase in false prozone flags. |
| Root cause | Under Investigation by firm |
| Action | Binding Site sent an Important Notice dated October 28, 2016, to all affected customers. . Binding Site requests the following: - Immediately quarantine and dispose of any LK018.S lot 400012 / LK018.10S lot 400257 kits held in your organisation; - Remove any affected lots from the SPAPLUS instrument; - Contact Binding Site representative to request replacement kits; - Return completed E-back form to your local Binding Site representative. For questions regarding this recall call 858-453-9177. |
| Quantity | 3,088 |
| Distribution | Worldwide Distribution - U.S. (nationwide) and Internationally to the following; Canada, Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062372 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER The Binding Site, Ltd., Jun 21, 2007 |