Recall Z-2049-2013
Sarken, Inc. · initiated July 29, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Codes / lots: Manufacturer's Product Number DOA-254 Lot Number DOA2050035 DOA2090666 DOA2110059 DOA2120771 Expiration Date: 02/2014 07/2014 08/2014 10/2014
Reason for recall
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.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-2049-2013
- Initiated
- July 29, 2013
- Posted by FDA
- August 23, 2013
- Terminated
- July 16, 2014
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Quantity
- various quantities
- Distribution
- Worldwide Distribution - US Nationwide in the country Virgin Islands
- Recalling firm
- Sarken, Inc., Tempe, AZ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2048-2013 Class II | SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY…These products are being recalled because they were distributed without adequate labeling and instructions… | 07/29/2013Terminated |
| Z-2050-2013 Class II | SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC USE ONLY…These products are being recalled because they were distributed without adequate labeling and instructions… | 07/29/2013Terminated |
| Z-2051-2013 Class II | SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC USE ONLY…These products are being recalled because they were distributed without adequate labeling and instructions… | 07/29/2013Terminated |
| Z-2052-2013 Class II | SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY…These products are being recalled because they were distributed without adequate labeling and instructions… | 07/29/2013Terminated |
| Z-2053-2013 Class II | SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY…These products are being recalled because they were distributed without adequate labeling and instructions… | 07/29/2013Terminated |