Z-0943-2021Class II

Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A

Name: Z-0943-2021 Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
Creator: The Binding Site Group, Ltd.
Published: 2020-11-18
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2020-11-18 / Terminated

FDA source

The Binding Site Group, Ltd. began a recall of Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A on 2020-11-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0943-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-18
Posted: 2021-02-01
Terminated: 2024-12-23
Recalling firm: The Binding Site Group Ltd.
Product: Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
Product code: DFH Kappa, Antigen, Antiserum, Control
Reason for recall: 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.
FDA 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 [email protected] 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: [email protected] Customers in the USA may choose to instead contact the local representative at: Telephone: 800-633-4484 [email protected]
Quantity in commerce: 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
Product codes and lots: Model Number: LK016.M.OPT.A UDI: 05051700019866 Lot Number: 454763

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0943-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0943-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-10	2021-02-01

Product code DFH

K173732Class IIOptilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free KitThe Binding Site Group , Ltd. / cleared 2018-08-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)