Recall Z-0274-2022— The Binding Site Group, Ltd.

Name: FDA recall Z-0274-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-15

Class II · Terminated

Class II FDA medical device recall by The Binding Site Group, Ltd., initiated 2021-10-15, terminated 2025-02-04. It names one FDA 510(k) clearance: K140396. 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: 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..

Recalling firm: The Binding Site Group, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2021-10-15
Terminated: 2025-02-04
Firm location: Birmingham, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K140396 — FREELITE HUMAN LAMBDA FREE KITThe Binding Site Group , Ltd.·cleared 2014-04-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.