FDA Medical Device Recalls (openFDA)
The Binding Site Group, Ltd.: Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
- Recall number
- Z-1050-2017
- Recalling firm
- The Binding Site Group, Ltd.
- Product
- Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
- Status
- Terminated
- Initiated
- 2012-11-28
- Posted
- 2017-01-19
- Terminated
- 2017-03-03
- Reason
- Calibration curve activity has increased over time in the kit lots listed.
- Root cause
- Unknown/Undetermined by firm
- Action
- 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.
- Quantity
- 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, Taiwan, Belgium, France, Italy, Spain.
- Lot, serial or model codes
- Lot #323278, 327963
- 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