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K-ASSAY® IgG Reagent

KAMIYA BIOMEDICAL COMPANY, LLC · Model KAI-014 · UDI-DI 00816426020108

DEW Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

For the quantitative determination of human IgG in serum by immunoturbidimetric assay.

Recalls

Date	Firm	Reason
2024-07-31	Beckman Coulter Inc.	Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
2018-05-16	Abbott Laboratories, Inc	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
2010-06-28	Beckman Coulter Inc.	The recall was initiated after Beckman Coulter Inc. confirmed reports of high recovery of immunoglobulin A (IgA) in proficiency surveys or patient samples using Synchron Ig-A reage
2003-06-06	Beckman Coulter Inc	low level IgM serum sample results may be suppressed and an error code generated when using affected lots. Error codes are seen as E60 or E66.

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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.