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Recall Observatory FDA recall evidence

Device product

SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).

Z-2053-2013

July 29, 2013

Class II

Product summary

Firm
Sarken, Inc.
Event
Event 65841
Status
Terminated
Classification
Class II
Quantity
various quantities
Official record key
device-enforcement:Z-2053-2013

Official wording

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.

Code information: Manufacturer's Product Number DOP-114 Lot Number OPI2100003 Expiration Date: 09/2014

Distribution pattern: Worldwide Distribution - US Nationwide in the country Virgin Islands

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.