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U.S. Department of Health and Human Services

Class 2 Device Recall Cobas Homocysteine Enzymatic Assay

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  Class 2 Device Recall Cobas Homocysteine Enzymatic Assay see related information
Date Initiated by Firm March 23, 2015
Date Posted May 15, 2015
Recall Status1 Terminated 3 on January 19, 2016
Recall Number Z-1622-2015
Recall Event ID 71034
510(K)Number K113793  
Product Classification Urinary homocystine (nonquantitative) test system - Product Code LPS
Product Homocysteine test system - Homocysteine Reagent.
05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA

Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems.
Code Information 05385415190, Homocysteine 100Tests, cobas c, COBAS INTEGRA  Lot number 69781101
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Roche Support Network Customer Support C
800-428-2336
Manufacturer Reason
for Recall		 Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This negative bias could, in the worst case, lead to inaccurately low Homocysteine results. An elevated level of Homocysteine is considered an important risk factor in the assessment of peripheral vascular disease. Falsely low values could lead to a delay of di
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Roche Diagnostics sent URGENT MEDICAL DEVICE CORRECTION notifications dated 3/23/2015 to affected direct accounts via UPS. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions.
Quantity in Commerce 2558 units
Distribution Nationwide Distribution-including PR and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, , SC, TN, TX, VA, WA, and WV.
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 = LPS and Original Applicant = ROCHE
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