FDA Medical Device Recalls (openFDA)
The Binding Site Group, Ltd.: Optilite IgG4 Kit Product Code: LK009.OPT.A
- Recall number
- Z-1089-2017
- Recalling firm
- The Binding Site Group, Ltd.
- Product
- Optilite IgG4 Kit Product Code: LK009.OPT.A
- Status
- Terminated
- Initiated
- 2016-12-23
- Posted
- not on file
- Terminated
- 2017-05-03
- Reason
- A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert
- Root cause
- Under Investigation by firm
- Action
- Customer notification letters were sent on 12/23/16. The Binding Site recommends to continue testing on the kit as normal and refer to the measuring ranges and limit of quantification stated in the notice and as indicated in the amended insert (INS009.OPT.A, Version: 21st December 2016) provided with this notification. The notice needs to be passed on to all those who need to be aware within the organization or to any Organization where the potentially affected devices have been transferred. Return the completed E-Back Form to your local Binding Site Representative for records and note that The Binding Site intends to report this correction to the FDA recall coordinator. If you have any questions contact Technical Services.
- Quantity
- 9 users
- Distribution
- U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution.
- Lot, serial or model codes
- Lot #401413
- 510(k) numbers
- ["K150526"]
- PMA numbers
- not on file
- Product code
- CFN
- 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