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U.S. Department of Health and Human Services

Class 3 Device Recall Henry Schein One Step Mono Rapid Test Device

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 Class 3 Device Recall Henry Schein One Step Mono Rapid Test Devicesee related information
Date Initiated by FirmJune 22, 2016
Create DateJuly 22, 2016
Recall Status1 Terminated 3 on January 29, 2018
Recall NumberZ-2268-2016
Recall Event ID 74505
510(K)NumberK042272 
Product Classification System, test, infectious mononucleosis - Product Code KTN
ProductHenry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
Code Information all lots are affected
Recalling Firm/
Manufacturer		 Alere San Diego, Inc.
9975 Summers Ridge Rd
San Diego CA 92121-2997
For Additional Information ContactCarmen Bergelin
858-805-2000 Ext. 3015
Manufacturer Reason
for Recall		The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionA Medical Device Correction letter dated 6/22/16 will be sent to all customers to inform them that Alere is recalling the MONO Rapid Test products because the Positive Control Information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect. Customers are informed that the labeling states the Positive Control contains the following: Diluted human plasma containing IM heterophile antibodies, 0.09% sodium azide. The Positive Control contains the following: Goat anti-mono antibody, 0.09% sodium azide. Customers are instructed to complete and fax or email the enclosed verification form within 10 days. Customers with questions are instructed to contact Alere San Diego at (844) 804-4945 or email at verfications.ts@alere.com.
DistributionUS
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KTN
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