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
This recall has been terminated (originally issued January 19, 2017).
- Company
- The Binding Site Group, Ltd.
- Recall Initiated
- October 28, 2016
- Posted
- January 19, 2017
- Terminated
- July 27, 2017
- Recall Number
- Z-1053-2017
- Quantity
- 3,088
- Firm Location
- Birmingham United Kingdom
- Official Source
- View on FDA website ↗
Reason for Recall
A change in the calibration curve causing an increase in false prozone flags.
Distribution
Worldwide Distribution - U.S. (nationwide) and Internationally to the following; Canada, Australia.
Lot / Code Info
Lot #400012, 400257
Root Cause
Under Investigation by firm
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.