FDAFDA · Food and drugs·Recall number Z-2049-2013
SARKEN STAT! Multi-Drug Test Panel 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 DOA-254 Lot Number DOA2050035 DOA2090666 DOA2110059 DOA2120771 Expiration Date: 02/2014 07/2014 08/2014 10/2014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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