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HYDRAGEL 9 IF MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK)

SEBIA · Model 4887 · UDI-DI 03607360048870

CFF Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2022-09-28	Kamiya Biomedical Company, LLC	IgA Reagent may start showing cloudiness over time, which can affect assay performance.
2022-04-06	Helena Laboratories, Corp.	Due to microbial growth causing interference with interpretation.
2017-07-21	Helena Laboratories, Corp.	The plates do not have wells punched for the controls in the patient 1 area.
2004-01-28	Beckman Coulter Inc	Inconsistent and incomplete results for IgG.

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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.