Reported Sep 4, 2013 · Terminated
SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation…
Sarken, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sarken, Inc. · 720 S Smith Rd · Tempe, AZ · 85281-2925
Is this the product you have?
- SARKEN STAT! 1-
- Panel Test Kit-OPI Product UsageLabeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing)
- Lot codes and dates
- Manufacturer's Product Number DOP-114
- Lot Number OPI2100003 Expiration Date09/2014
- Amount recalled
- various quantities
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
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 product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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