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Lambda light chains

SENTINEL CH. SPA · Model A26849 · UDI-DI 08058056681263

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510(k) clearances

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Recalls

Facilities

Description

The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 and Unicel DxC 600 Systems.

Recalls

Date	Firm	Reason
2021-10-15	The Binding Site Group, Ltd.	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, whic
2016-10-28	The Binding Site Group, Ltd.	A change in the calibration curve causing an increase in false prozone flags.
2016-07-05	The Binding Site Group, Ltd.	Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Therefore users moving to thi
2012-11-28	The Binding Site Group, Ltd.	Calibration curve activity has increased over time in the kit lots listed.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.