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ARCHITECT

Abbott GmbH · Model 2K98-11 · UDI-DI 00380740119409

JIQ JJX JIS Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Microalbumin Controls

Recalls

Date	Firm	Reason
2012-11-07	HemoCue AB	Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made from April1 st 2011 and onwards. In addition, a warranty statement was missing in the

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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.