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U.S. Department of Health and Human Services

Class 2 Device Recall Drew Scientific DREW 3PAC Reagent Kit

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  Class 2 Device Recall Drew Scientific DREW 3PAC Reagent Kit see related information
Date Initiated by Firm April 21, 2017
Create Date June 30, 2017
Recall Status1 Terminated 3 on January 06, 2020
Recall Number Z-2656-2017
Recall Event ID 77464
510(K)Number K071562  
Product Classification Counter, differential cell - Product Code GKZ
Product Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
Code Information Lot # 0868 Exp. Date 11/28/2018,  Lot # 0869 & Lot 0870 Exp. Date 01/10/2019,  Lot # 0871,0872, 0873, 0874 , 0875, and 0876 Exp. Date 02/06/2019, and  Lot # 0877, 0877, 0879, 0880, 0881, and 0882 Exp. Date 02/23/2019 
Recalling Firm/
Manufacturer		 JAS Diagnostics Inc.
14100 NW 57th Ct
Miami Lakes FL 33014-3107
For Additional Information Contact Customer Service Department
800-433-0945
Manufacturer Reason
for Recall		 May result in elevated platelet backgrounds during routine startup/background checks.
FDA Determined
Cause 2		 Material/Component Contamination
Action The firm sent notification of recall to consignees on 04/21/2017 by mail in domestic states, and by email or mail to foreign consignees. The notification informed consignees of the product removal. it instructed consignees to discontinue use, destroy product on hand, complete the product destruction form, and contact the firm's customer service department (305-324-2300 or 800-433-0945) to request product replacement.
Quantity in Commerce 14,064
Distribution AL, AR, CA, FL, GA, IA, IN, LA, MA, MN, MO, NC, NE, NY, SC, TN, TX, and Puerto Rico United Arab Emirates, Bolivia, Republic of C¿te dIvoire, Colombia, Costa Rica, Ecuador, Egypt, Indonesia, Iraq, Italy, Korea, Mexico, Russia, Philippines, Slovenia, Tunisia, Venezuela, and Vietnam
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 = GKZ and Original Applicant = DREW SCIENTIFIC, INC.
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