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U.S. Department of Health and Human Services

Class 3 Device Recall OraSure Methamphetamine Intercept Microplate EIA

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  Class 3 Device Recall OraSure Methamphetamine Intercept Microplate EIA see related information
Date Initiated by Firm February 05, 2021
Create Date March 05, 2021
Recall Status1 Terminated 3 on March 30, 2023
Recall Number Z-1183-2021
Recall Event ID 87340
510(K)Number K993208  
Product Classification Gas chromatography, methamphetamine - Product Code LAF
Product Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
Code Information Lot 6681090, Exp date 2021-03. UDI: 608337000191
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 of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but contained Substrate Reagent (TMB) lot 6679623, should not affect performance.
FDA Determined
Cause 2		 Packaging process control
Action Orasure issued Advisory Letters issued on 2/05/21 via Certified Mail receipt. Letter states reason for recall, health risk and action to take: OraSure Technologies, Inc. has generated a new Specification Sheet for the Methamphetamine Kit with the alternate Substrate Reagent Lot 6679623 included with this advisory letter. Retain testing done using the alternate Substrate Reagent revealed no impact to the kit's performance. If you have any questions regarding this issue please contact out Technical Services Department at technicalserviceQcorasure.coin and they can assist you
Quantity in Commerce 16 units
Distribution US Nationwide distribution in the states of KS, NJ, OH, VA.
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 = LAF and Original Applicant = ORASURE TECHNOLOGIES, INC.
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