SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR… — Class II medical device recall Z-2051-2013
Terminated recall by Sarken, Inc., reported 2013-09-04, distributed nationwide. These products are being recalled because they were distributed without adequate labeling and instructions for
| Recall number | Z-2051-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sarken, Inc., Tempe, AZ, United States |
| Recall initiated | 2013-07-29 |
| Classified | 2013-08-23 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2014-07-16 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | COC2010004, COC2110076 |
| Expiration dates | 2013-12 |
Product
SARKEN STAT! 1- Panel Test Kit-COC 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2051-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.