The Recall Desk

FDA (Devices) recall action 65841

Sarken, Inc. recalled 6 products on 2013-09-04

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2013-09-04
Critical
0
Units
—

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–6 of 6

  • ModerateFDA (Devices)··2013-09-04

    Sarken STAT! 1-Panel Test Kit Recalled for Inadequate Labeling

    Sarken, Inc. is recalling STAT! 1-Panel Test Kits because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect results.

    Product
    SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2013-09-04

    Sarken STAT! Multi-Drug Test Panel Recalled for Inadequate Labeling

    Sarken, Inc. is recalling STAT! Multi-Drug Test Panels because they were distributed without adequate labeling and instructions for use, which could lead to misuse and incorrect test results.

    Product
    SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2013-09-04

    Sarken STAT! Multi-Drug Test Panel Recalled for Inadequate Labeling

    Sarken, Inc. is recalling STAT! Multi-Drug Test Panels because they were distributed without adequate labeling and instructions for use, which could lead to misuse and incorrect test results.

    Product
    SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2013-09-04

    Sarken THC Test Kits Recalled for Inadequate Labeling and Instructions

    Sarken, Inc. is recalling SARKEN STAT! 1-Panel Test Kits-THC because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect results.

    Product
    SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2013-09-04

    Sarken STAT! 1-Panel Test Kit Recalled for Inadequate Labeling

    Sarken, Inc. is recalling STAT! 1-Panel Test Kits because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect test results.

    Product
    SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2013-09-04

    Sarken STAT! 1-Panel Test Kit Recalled for Inadequate Labeling

    Sarken, Inc. is recalling STAT! 1-Panel Test Kits because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect test results.

    Product
    SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
    Category
    Distribution
    1 state