Class 3 Device Recall Cocaine Metabolite MICROPLATE EIA

• Date Initiated by Firm: December 20, 2017
• Create Date: April 18, 2018
• Recall Status: Terminated 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
• FEI Number: 2528909
• 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: 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