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U.S. Department of Health and Human Services

Class 3 Device Recall SeraQuest CMV IgM

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  Class 3 Device Recall SeraQuest CMV IgM see related information
Date Initiated by Firm September 28, 2010
Date Posted January 23, 2012
Recall Status1 Terminated 3 on May 31, 2012
Recall Number Z-0837-2012
Recall Event ID 58551
510(K)Number K982485  
Product Classification Antibody igm,if, cytomegalovirus virus - Product Code LKQ
Product SeraQuest***CMV IgM TEST SET For the detection of CMV IgM Antibodies 96 Test Set Cat. No. 01-150 Store 2-8 C For In Vitro Diagnostic Use***Contents: 1 96 wells bag with holder, 1 Negative Control*, 1 Positive Control*, 1 Substrate, 1 Stop Solution, 1 Conjugate*, 1 Calibrator 1*, 1 Calibrator 2*, 1 Diluent for Specimen*, 1 Wash Concentrate*, *Contains Sodium Azide Lot No. E1700 Doral, FL 33122 USA Exp. Date: May 11.

BIORAD***CMV IgM EIA For the detection of CMV IgM Antibodies Xn-HARMFUL Cat. No. 25178 96 Test Set Store 2-8 C ID: grey For In Vitro Diagnostic Use*** Contents: I CMV IgM Microplate (96 wells), 1 Negative Control* (0.6 mL), 1 Positive Control (0.6 mL), 1 Substrate (12 mL), 1 Stop Reagent (12 mL), 2 Conjugate* (12 mL), 1 Calibrator 1* (0.6 mL), 1 Calibrator 2* (0.6 mL) , 1 Diluent* (25 mL), 1 Wash Concentrate* (30 mL), *0.1% Sodium Azide Lot No. E1700 Distributed by: Bio-Rad Laboratories-Redmond, WA 98052.
Code Information Lot Number: E1700
Recalling Firm/
Quest International, Inc.
8127 NW 29th St
Doral FL 33122
For Additional Information Contact Oscar R. Compain
Manufacturer Reason
for Recall
Quest International recalled their CMV IgM Test kit because the device failed the test run due to lack of activity in the coated wells.
FDA Determined
Cause 2
Action On September 28, 2010, Quest International, Inc. issued a Memo to its Customers who received the CMV IgM Lot E1700. The memo identified the affected product and stated the problem with the device. The memo asked customers to let the firm know if they had any remaining inventory from the affected lot and the product would be replaced immediately. Questions should be directed to 305-592-6991.
Quantity in Commerce 315
Distribution Nationwide Distribution -- Washington and California.
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 = LKQ and Original Applicant = QUEST INTL., INC.