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Autokit Micro Albumin

FUJIFILM WAKO PURE CHEMICAL CORPORATION · Model 999-06001 · UDI-DI 04987481164666

JIQ Prescription
1
510(k) clearances
20
Adverse events
1
Recalls
22
Facilities

Description

In-Vitro Diagnostic Use

Recalls

DateFirmReason
2012-11-07HemoCue ABIncorrect 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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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.