FDA Medical Device Recalls (openFDA)
The Binding Site Group, Ltd.: Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
- Recall number
- Z-0943-2021
- Recalling firm
- The Binding Site Group, Ltd.
- Product
- Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
- Status
- Terminated
- Initiated
- 2020-11-18
- Posted
- not on file
- Terminated
- 2024-12-23
- Reason
- Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values.
- Root cause
- Under Investigation by firm
- Action
- On 11/30/2020, the firm emailed an "Urgent Field Safety Notice" to its U.S. Customers informing them that investigations have confirmed that the quality control (QC), high and low controls, provided with specific product and lot numbers are consistently demonstrating a ~15% positive bias compared to assigned values and customers may experience QCs consistently reporting results close to the upper acceptable limits, and QC failures may occur on the affected products. Customer are instructed: 1. Users may continue to use any remaining kits of the affected product in their stock. As per the product package insert sample results obtained should only be accepted if the control results are within +/-20% of the concentrations stated on the QC certificate provided. 2. To complete the E-Back Form TSWS18 to Technical.support@bindingsite.com or to their local representative within one week of receiving this notification. Customers are also instructed: -To pass on the notification to all those who need to be aware within their organization or to any organization where the potentially affected devices have been transferred. -To transfer this notification to other organizations on which the information has an impact. -To maintain awareness on this notification for any appropriate period. Any questions, contact the local representative or Technical Support Group: UK technical support is: Telephone: +44(0) 1214569696 Email: technical.support@bindingsite.com Customers in the USA may choose to instead contact the local representative at: Telephone: 800-633-4484 Us-tsc@Bindingsite.com
- Quantity
- 213 kits in the U.S.
- Distribution
- U.S.: CO, FL, IA, MA, NC, NJ, NY, OH, SD, and UT. O.U.S.: Not provided
- Lot, serial or model codes
- Model Number: LK016.M.OPT.A UDI: 05051700019866 Lot Number: 454763
- 510(k) numbers
- ["K173732"]
- PMA numbers
- not on file
- Product code
- DFH
- 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
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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