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

Recall Z-1913-2019 — ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum

U.S. FDA — Device Enforcement · United States · 2019-05-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1913-2019
Date of alert: 2019-05-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Siemens Healthcare Diagnostics, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10729780

Reported risk: A steady upward trend in blank (u) absorbance was observed

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

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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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