FDA Medical Device Recalls (openFDA)
The Binding Site Group, Ltd.: 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
- Recall number
- Z-1053-2017
- Recalling firm
- The Binding Site Group, Ltd.
- Product
- 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
- Status
- Terminated
- Initiated
- 2016-10-28
- Posted
- 2017-01-19
- Terminated
- 2017-07-27
- Reason
- A change in the calibration curve causing an increase in false prozone flags.
- Root cause
- Under Investigation by 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.
- Quantity
- 3,088
- Distribution
- Worldwide Distribution - U.S. (nationwide) and Internationally to the following; Canada, Australia.
- Lot, serial or model codes
- Lot #400012, 400257
- 510(k) numbers
- ["K062372"]
- PMA numbers
- not on file
- Product code
- DEH
- Firm FEI
- 3002808340
- Firm city
- Birmingham
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28