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U.S. Department of Health and Human Services

Class 2 Device Recall Elecsys PreciControl Varia 3

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  Class 2 Device Recall Elecsys PreciControl Varia 3 see related information
Date Initiated by Firm April 10, 2017
Date Posted May 31, 2017
Recall Status1 Terminated 3 on August 04, 2017
Recall Number Z-2173-2017
Recall Event ID 77108
510(K)Number K111506  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product Elecsys PreciControl Varia 3
Code Information Lot Number: 189285 Expiration Date: 10/31/2017 Part Number: PreciControl Varia: 05618860160
Recalling Firm/
Manufacturer		 Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Roche Support Network Customer Support C
800-428-2336
Manufacturer Reason
for Recall		 e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays
FDA Determined
Cause 2		 Process control
Action On 4/10/2017, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected consignees via courier. The recall notifications 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 about the information contained in this UMDC.
Quantity in Commerce 1603
Distribution Nationwide
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 = JJY and Original Applicant = Roche Diagnostics
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