Recall Z-2048-2013 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Sarken, Inc.
SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
| Date | Aug 23, 2013 (initiated Jul 29, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | Firm notified customers via telephone, followed up with MEDICAL DEVICE RECALL letter dated July 29, 2013 sent 08/02/13, via USPS regular mail to all affected customers. The recall notification letter is accompanied by a return response, acknowledgement and receipt form. The letter notify customers of the voluntary recall, product description (with prodcut images), reason for recall, potential impact, instructions/actions to follow, and contact information. |
| Quantity | various quantities |
| Distribution | Worldwide Distribution - US Nationwide in the country Virgin Islands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.