FDAFDA · Food and drugs·Recall number Z-2051-2013
SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing) .
Published September 4, 2013 · Recall initiated: July 29, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sarken, Inc.
- Distributor
- Worldwide Distribution - US Nationwide in the country Virgin Islands
- Lot
- Manufacturer's Product Number DCO-114 Lot Number COC2010004 COC2110076 Expiration Date: 12/2013 09/2014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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