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Recall Observatory FDA recall evidence

Device product

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

Z-0943-2021

November 18, 2020

Class II

Product summary

Firm
The Binding Site Group, Ltd.
Event
Event 86926
Status
Terminated
Classification
Class II
Quantity
213 kits in the U.S.
Official record key
device-enforcement:Z-0943-2021

Official wording

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.

Code information: Model Number: LK016.M.OPT.A UDI: 05051700019866 Lot Number: 454763

Distribution pattern: U.S.: CO, FL, IA, MA, NC, NJ, NY, OH, SD, and UT. O.U.S.: Not provided

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.