Date Initiated by Firm |
July 13, 2020 |
Create Date |
August 24, 2020 |
Recall Status1 |
Terminated 3 on June 08, 2021 |
Recall Number |
Z-2876-2020 |
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 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB |
Code Information |
Lot Number: 6673115 Exp. Date:03/31/2020 UDI: 608337000238 |
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 |
39 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.
|