Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-3138-2017 — K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Alpha-1 Acid Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4, Haptoglobin, lgA, lgG,

U.S. FDA — Device Enforcement · United States · 2017-07-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3138-2017
Date of alert: 2017-07-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Kamiya Biomedical Company, LLC
Product category: device
Product type: Devices

Reported risk: The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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