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U.S. Department of Health and Human Services

Class 3 Device Recall IMO402 Mononucleosis Rapid Test Device

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 Class 3 Recall
IMO402 Mononucleosis Rapid Test Device
see related information
Date Posted April 18, 2013
Recall Status1 Terminated on August 29, 2013
Recall Number Z-1148-2013
Recall Event ID 64790
Premarket Notification
510(K) Number
K042272 
Product Classification System, Test, Infectious Mononucleosis - Product Code KTN
Product IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosis of infectious Mononucleosis.
Code Information The affected control lot number is 11030386. Lot/Unit Codes: MON1040008 & MON1040016.
Recalling Firm/
Manufacturer
Alere San Diego, Inc.
9975 Summers Ridge Rd
San Diego, California 92121-2997
Manufacturer Reason
for Recall
Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
Action Alere sent an Urgent Medical Device Recall letter dated February 26, 2013, to all affected customers. The letter informs the customers of the problems identified and the actions to be taken. Customers with unused product remaining are instructed to immediately discard it. Investigations of customer complaints indicate that the positive control included with this lot may produce false negative results. Customers are instructed to return the attached Verification form. Customers that have consumed all product are instructed to indicate zero under "Quantity Discarded" and complete and fax back the form. Replacement product will be provided for any unused portion of the affected lot based on completion and return of the attached Verification Form. Customers with any questions are instructed to contact Alere Technical Services at (866) 216-0094 or by email at later.flow.support@alere.com. For questions regarding this recall call 858-805-2000, ext 3015.
Quantity in Commerce 78 kits
Distribution Nationwide Distribution including TN, WA, UT, KS, KY, MN, GA, MA, PA, NY, VT, and the Dist. of Columbia
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KTN and Original Applicant = ACON LABORATORIES, INC.
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