FDA Medical Device Recalls (openFDA)
The Binding Site Group, Ltd.: Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.
- Recall number
- Z-1043-2017
- Recalling firm
- The Binding Site Group, Ltd.
- Product
- Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.
- Status
- Terminated
- Initiated
- 2016-07-05
- Posted
- 2017-01-18
- Terminated
- 2017-07-03
- Reason
- Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Therefore users moving to this batch will see results >114mg/L giving lower results and conversely when switching to the next batch results will be seen to shift upwards.
- Root cause
- Under Investigation by firm
- Action
- On 07/05/16 notification letters were sent to customers. The Binding Site Group requests the following: - Immediately Quarantine & Dispose of any LK018.OPT lot 405566 kits within stock; - Remove any affected lots from the Optilite instrument; - Patients with Lambda Freelite results >114mg/L should be reviewed in consultation with clinicians, alongside other clinical findings and retested where applicable; - Notify local Binding Site representative to request replacement kits; - Return completed E-Back Form to local Binding Site Representative; The firm recommended that the notice be circulated to those within the organization who need to be aware.
- Quantity
- 809 kits
- Distribution
- U.S. distribution to the following; AR, PA, GA, NC, KY, VA, CA. Foreign distribution to the following; Uk, Germany, France, Italy, Spain, Czech Republic, Portugal, Belgium.
- Lot, serial or model codes
- Lot #405566, 405567
- 510(k) numbers
- ["K150658"]
- 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