Z-2049-2013 Class II Terminated
FDA device recall Z-2049-2013 was initiated by Sarken, Inc. on July 29, 2013 and is designated Class II. Reason for recall: 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 result… The recall status is terminated (terminated July 16, 2014). Affected quantity: various quantities.
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2013
- Initiation Date
- July 29, 2013
- Termination Date
- July 16, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- various quantities
Product Description
SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing) .
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US Nationwide in the country Virgin Islands
Code Information
Manufacturer's Product Number DOA-254 Lot Number DOA2050035 DOA2090666 DOA2110059 DOA2120771 Expiration Date: 02/2014 07/2014 08/2014 10/2014