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Device Recall VisuaLine Single Dip Oxycodone
Model / Serial
Sun Biomedical Part Numbers: 15-2016; Product lot number Vis-OXD-dip 07-018-1-275 or Vis OXD-Dip 07-081-257.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Class II Recall - Nationwide Distribution --- including states of NJ, TN, LA, GA, AZ, PA, NE, OH, ME, DE, VA, and CT.
Product Description
VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.
Manufacturer
Sun Biomedical Laboratories, Inc.
1 Event
Recall of Device Recall VisuaLine Single Dip Oxycodone
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Manufacturer
Sun Biomedical Laboratories, Inc.
Manufacturer Address
Sun Biomedical Laboratories, Inc., 1001 Lower Landing Rd, Blackwood NJ 08012-3124
Source
USFDA
Language
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