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U.S. Department of Health and Human Services

Class 2 Device Recall Homocysteine Enzymatic Assay

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  Class 2 Device Recall Homocysteine Enzymatic Assay see related information
Date Initiated by Firm October 04, 2019
Create Date December 13, 2019
Recall Status1 Terminated 3 on October 09, 2020
Recall Number Z-0679-2020
Recall Event ID 84018
510(K)Number K113793  
Product Classification Urinary homocystine (nonquantitative) test system - Product Code LPS
Product Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems
Catalog Number: 06542921190 - - Product Usage: The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria.
Code Information Lot Number: 422313  Exp Date: 07/31/2020
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact SAME
317-521-4343
Manufacturer Reason
for Recall		 Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
FDA Determined
Cause 2		 Device Design
Action The Urgent Medical Device Correction (UMDC) was sent via Roche issued Urgent Medical Device notification via FedEx (signature required) to the consignee list on 10/04/2019. The letter states issue, health risk nd action to take: Discontinue use and discard the remaining affected product in inventory according to local waste guidelines. Because a replacement lot is currently not available, Roche will issue credit for Homocysteine cobas c packs, lot number 422313, remaining in your inventory. If customers have another validated system (i.e. cobas c501/502) in their lab and wish to set up the Roche Homocysteine assay on one of these modules (different catalog number than that subject to this recall), they will be instructed to contact a Roche Field Specialist for support. " A reimbursement for send out testing to an accredited laboratory will also be provided for those customers without another Roche system available. 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 about the information The UMDC will also be posted to the diagnostics.roche.com website.
Quantity in Commerce 82 units (US)
Distribution US Nationwide distribution in the states of NJ, HI, IA.
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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