[Recalled] SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing) . — These products are being recalled because they were distributed without adequat… | FDA 2013-07-
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing) . |
|---|---|
| Brand / manufacturer | Sarken, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2052-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 29 July 2013 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Sarken, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.