Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monit
FDA device recall Z-1053-2017 · posted 2017-01-19 · Terminated
Recall details
- Recalling firm
- The Binding Site Group, Ltd.
- Reason for recall
- A change in the calibration curve causing an increase in false prozone flags.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- DEH
- Quantity affected
- 3,088
- Distribution
- Worldwide Distribution - U.S. (nationwide) and Internationally to the following; Canada, Australia.
- Date initiated
- 2016-10-28
- Date posted
- 2017-01-19
- Date terminated
- 2017-07-27
- 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 |