Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma an
FDA device recall Z-1050-2017 · posted 2017-01-19 · Terminated
Recall details
- Recalling firm
- The Binding Site Group, Ltd.
- Reason for recall
- Calibration curve activity has increased over time in the kit lots listed.
- Action taken
- 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.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- DEH
- Quantity affected
- 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, Tai
- Date initiated
- 2012-11-28
- Date posted
- 2017-01-19
- Date terminated
- 2017-03-03
- Location
- Birmingham, United Kingdom
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER (K062372) | The Binding Site, Ltd. | 2007-06-21 |