Recall Z-2048-2013— Sarken, Inc.
Class II · Terminated
Class II FDA medical device recall by Sarken, Inc., initiated 2013-07-29, terminated 2014-07-16. FDA's recall record names no specific 510(k) clearance for this event. Product: SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing) .. Reason: 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..
- Recalling firm
- Sarken, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-29
- Terminated
- 2014-07-16
- Firm location
- Tempe, AZ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.