Recall Z-1050-2017 ยท DEH Lambda, Antigen, Antiserum, Control
The Binding Site Group, Ltd.
Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
| Date | Jan 19, 2017 (initiated Nov 28, 2012) |
| Status | Terminated |
| Reason | Calibration curve activity has increased over time in the kit lots listed. |
| Root cause | Unknown/Undetermined by firm |
| Action | Customer notification letters were sent 11/28/12. Customers were asked to discontinue using the listed kit lots. Discard any unused or partially-used kits of these lots. Let The Binding Site know how many replacement kits are required. |
| Quantity | 1,002 |
| Distribution | U.S. distribution to the following; CA, TX, HI, GA, PA, UT, NY, OK, ID, MA, AZ. Foreign distribution to the following; Australia, Bulgaria, Denmark, Hong Kong, Ireland, Israel, Japan, New Zealand, Taiwan, Belgium, France, Italy, Spain. |
| 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 |