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
Reported: December 1, 2021 Initiated: October 15, 2021 #Z-0274-2022
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.
Details
- Recalling Firm
- The Binding Site Group, Ltd.
- Units Affected
- 2,254 kits
- Distribution
- U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada
- Location
- Birmingham
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by The Binding Site Group, Ltd.. Units affected: 2,254 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 1, 2021. Severity: Moderate. Recall number: Z-0274-2022.
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