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APO A-I

RANDOX LABORATORIES LIMITED · Model LP2116 · UDI-DI 05055273204339

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Intended for the quantitative in vitro determination of Apolipoprotein A-I (APO A-I) in serum and plasma

Recalls

Date	Firm	Reason
2025-04-23	Beckman Coulter Ireland, Inc.	The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B pat

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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.