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
FDA Recall Z-1053-2017 · Posted 2017-01-19
Recalling FirmThe Binding Site Group, Ltd.
Recall StatusTerminated
Product CodeDEH
Date Initiated2016-10-28
Date Terminated2017-07-27
Product Quantity3,088
Reason for Recall
A change in the calibration curve causing an increase in false prozone flags.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution - U.S. (nationwide) and Internationally to the following; Canada, Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.