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Recall Observatory FDA recall evidence

Device product

Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S

Z-0274-2022

October 15, 2021

Class II

Product summary

Firm
The Binding Site Group, Ltd.
Event
Event 88921
Status
Terminated
Classification
Class II
Quantity
2,254 kits
Official record key
device-enforcement:Z-0274-2022

Official wording

Reason: Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.

Code information: Model Number: LK018.S UDI Code: 05051700006477 Lot Number: 472776 Model Number:LK018.10S UDI Code: 05051700012201 Lot Number: 472664

Distribution pattern: U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.