The Binding Site Group, Ltd. FDA Recalls

3 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 ProduClass IIApr 16, 2026It was reported that plates 2 and 3 were marked as passed ,	It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been perform	Class IIDevices	Apr 16, 2026
Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPClass IIOct 15, 2021Due to calibration curves producing a higher activity than r	Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease	Class IIDevices	Oct 15, 2021
FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas Class IIMay 20, 2021The high and low level "Quality Controls" demonstrate a po	The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assig	Class IIDevices	May 20, 2021