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

Recall Z-2053-2013 — SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).

U.S. FDA — Device Enforcement · United States · 2013-07-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2053-2013
Date of alert
2013-07-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Sarken, Inc.
Product category
device
Product type
Devices
Reported risk: These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.
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.

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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.