Z-0274-2022 Class II Terminated
FDA device recall Z-0274-2022 was initiated by The Binding Site Group, Ltd. on October 15, 2021 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated February 4, 2025). Affected quantity: 2,254 kits.
Recall Details
- Product Type
- Devices
- Report Date
- December 1, 2021
- Initiation Date
- October 15, 2021
- Termination Date
- February 4, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,254 kits
Product Description
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
Reason for Recall
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.
Distribution Pattern
U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada
Code Information
Model Number: LK018.S UDI Code: 05051700006477 Lot Number: 472776 Model Number:LK018.10S UDI Code: 05051700012201 Lot Number: 472664