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

Recall Z-0463-2013 — Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activ

U.S. FDA — Device Enforcement · United States · 2012-10-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0463-2013
Date of alert: 2012-10-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Sekisui Diagnostics Llc
Product category: device
Product type: Devices

Reported risk: Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standard reducing the slope of the standard curve requiring more frequent sample dilutions.

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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