FDA recall Z-0274-2022

The Binding Site Group, Ltd. · Class II · 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

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

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

Key facts

Status: Terminated
Initiation date: 2021-10-15
Report date: 2021-12-01
Termination date: 2025-02-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Birmingham, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0274-2022