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U.S. Department of Health and Human Services

Class 2 Device Recall Triad Alcohol Prep Pads

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  Class 2 Device Recall Triad Alcohol Prep Pads see related information
Date Initiated by Firm February 28, 2011
Date Posted June 24, 2011
Recall Status1 Terminated 3 on February 29, 2012
Recall Number Z-2661-2011
Recall Event ID 59064
510(K)Number K092987  
Product Classification Test, time, prothrombin - Product Code GJS
Product 0200086, Triad Alcohol Prep Pads, 100 box
0200432, Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or
Hemosense INRatio 2 Prothrombin Time/lNR Testing Kit, Self-Test System;
0100007, Alcohol Prep Pads, packaged in the Hemosense INRatio Prothrombinme/lNR Testing Kit, Self-
Test System;
0100072, Alcohol Prep Pads, packaged in the INRatio Starter Kit
Code Information Lot/Unit Codes: Applicable to all INRatio kit lots packaged Triad Alcohol prep pads from 4/19/09 through 2/7/11, including the following:  218494,220447,223941,223943,224250,224251,224770,224771,224772,225544,229364,229365, 229366,229367,229368,229369,229370,229371,235188,235189,236334,236335,236336,238868, 238869,239283,239418,239419,239595,243020,243021,243413,243414,243415,243416,243417, 243418,243855,243856,243857,243858,243859,243860,243861,243862,243863,243864,243865, 244432,245759,245760,245761,245762,245763,245764
Recalling Firm/
Manufacturer		 Alere San Diego
9975 Summers Ridge Rd
San Diego CA 92121-2997
For Additional Information Contact Carmen Bergelin
858-455-4808 Ext. 3015
Manufacturer Reason
for Recall		 The recall of the Triad Group alcohol prep products is due to potential contamination of these products with the bacteria Bacillus cereus, which could lead to life-threatening infections.
FDA Determined
Cause 2		 Other
Action Alere sent a CUSTOMER NOTIFICATION letter on February 28, 2011 to all affected custumers. The letter included; description of product, affected lots, statement of potential for contamination which could lead to life-threatening infections. Alere asked its customers to discard the Triad Alcohol Prep Pads provided and complete and FAX the enclosed Verification Form within 10 days to confirm receipt of notice and to indicate the number of discarded/required replacement alcohol prep pads. The letter instructed customers to call Alere Technical Services for additional information at 888-246-7483.
Quantity in Commerce Estimated 4829 total units
Distribution Worldwide Distribution--(USA) Nationwide and countries of Canada, Australia, Japan and Puerto Rico
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 = GJS and Original Applicant = BIOSITE INCORPORATED
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