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ALB

RANDOX LABORATORIES LIMITED · Model AB3800 · UDI-DI 05055273200034

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510(k) clearances

Adverse events

Recalls

Facilities

Description

An Albumin test system is a device intended for the quantitative in vitro determination of Albumin concentration in serum and plasma.

Recalls

Date	Firm	Reason
2019-03-18	Roche Diagnostics Corporation	The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.

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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.