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U.S. Department of Health and Human Services

Class 3 Device Recall Orasure Technologies Interept

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  Class 3 Device Recall Orasure Technologies Interept see related information
Date Initiated by Firm July 13, 2020
Create Date August 24, 2020
Recall Status1 Terminated 3 on June 08, 2021
Recall Number Z-2877-2020
Recall Event ID 86122
510(K)Number K013882  
Product Classification Enzyme immunoassay, benzodiazepine - Product Code JXM
Product Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT
Code Information Lot Number: 6673116 Exp. Date:03/31/2020  
Recalling Firm/
Manufacturer		 OraSure Technologies, Inc.
220 E 1st St
Bethlehem PA 18015-1360
For Additional Information Contact SAME
610-882-1820
Manufacturer Reason
for Recall		 Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
FDA Determined
Cause 2		 Under Investigation by firm
Action OraSure Technologies issued Advisory Letter dated July 17,2020 via email stating reason for letter and action to take: While this kit expired at the end of March, 2020; we wanted to take this opportunity to send an updated Specification Sheet with the lot number of the Oral Fluid Negative Calibrator corrected for your files. If you have any questions regarding this issue please contact ourTechnical Services Department at technicalservice@orasure.com and they can assist you .
Quantity in Commerce 13 kits
Distribution Worldwide distribution - US Nationwide distribution including in the states of DC, FL, PA, MD, NM, NY, NV, PA and the country of France.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JXM and Original Applicant = ORASURE TECHNOLOGIES, INC.
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