RecallRadar

FDA Device recall Z-2051-2013

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

On 2013-09-04 the FDA classified a Class II recall of SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing) by Sarken, citing 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 i….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2051-2013
ClassificationClass II
Statusterminated
Initiated2013-07-29
Published2013-09-04
Last updated2026-09-13 11:53 UTC
CompanySarken
DistributionUS

Product

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

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.

Identifiers

code_infoManufacturer's Product Number DCO-114 Lot Number COC2010004 COC2110076 Expiration Date: 12/2013 09/2014

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2051-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.