FDA Medical Device Recalls (openFDA)
Sarken, Inc.: SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
- Recall number
- Z-2053-2013
- Recalling firm
- Sarken, Inc.
- Product
- SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
- Status
- Terminated
- Initiated
- 2013-07-29
- Posted
- 2013-08-23
- Terminated
- 2014-07-16
- 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.
- Root cause
- Other
- Action
- Firm notified customers via telephone, followed up with MEDICAL DEVICE RECALL letter dated July 29, 2013 sent 08/02/13, via USPS regular mail to all affected customers. The recall notification letter is accompanied by a return response, acknowledgement and receipt form. The letter notify customers of the voluntary recall, product description (with prodcut images), reason for recall, potential impact, instructions/actions to follow, and contact information.
- Quantity
- various quantities
- Distribution
- Worldwide Distribution - US Nationwide in the country Virgin Islands
- Lot, serial or model codes
- Manufacturer's Product Number DOP-114 Lot Number OPI2100003 Expiration Date: 09/2014
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DJG
- Firm FEI
- 3000297792
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28