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Dimension Vista® Flex® reagent cartridge KAPPA

Siemens Healthcare Diagnostics Products GmbH · Model 10465671 · UDI-DI 00842768024429

510(k) clearances

Adverse events

Recalls

Facilities

Description

For the quantitative measurement of immunoglobulin light chains, type kappa in human serum and plasma on the Dimension Vista® System

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.