SARKEN STAT! 1- Panel Test Kit-OPI Product Usage recall: Labeling Error
SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing) .
Why was SARKEN STAT! 1- Panel Test Kit-OPI Product Usage 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Manufacturer's Product Number DOP-114 Lot Number OPI2100003 Expiration Date: 09/2014
- Product
- SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing) .
- Recalling firm
- Sarken, Inc.
- Quantity
- various quantities
- Distribution
- Worldwide Distribution - US Nationwide in the country Virgin Islands
- Recall date
- September 4, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)