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U.S. Department of Health and Human Services

Class 3 Device Recall Cocaine Metabolite MICROPLATE EIA

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  Class 3 Device Recall Cocaine Metabolite MICROPLATE EIA see related information
Date Initiated by Firm December 20, 2017
Create Date April 18, 2018
Recall Status1 Terminated 3 on April 02, 2020
Recall Number Z-1419-2018
Recall Event ID 79534
510(K)Number K982061  
Product Classification Enzyme immunoassay, cocaine and cocaine metabolites - Product Code DIO
Product Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
Code Information Lot Number: 0006661251, Expiration date: 02/28/2018
Recalling Firm/
Manufacturer		 OraSure Technologies, Inc.
1745 Eaton Ave
Bethlehem PA 18018-1769
For Additional Information Contact Jose Rosado
610-882-1820 Ext. 1657
Manufacturer Reason
for Recall		 The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
FDA Determined
Cause 2		 Under Investigation by firm
Action The email to the firm's consignees states the controls will be replaced.
Quantity in Commerce 10
Distribution Distributed to 2 consignees in KS.
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 = DIO and Original Applicant = ORASURE TECHNOLOGIES, INC.
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