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U.S. Department of Health and Human Services

Class 3 Device Recall Tinaquant Complement C4 Test System

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 Class 3 Device Recall Tinaquant Complement C4 Test Systemsee related information
Date Initiated by FirmAugust 27, 2020
Create DateOctober 13, 2020
Recall Status1 Terminated 3 on May 22, 2024
Recall NumberZ-0103-2021
Recall Event ID 86406
510(K)NumberK012359 
Product Classification Complement c4, antigen, antiserum, control - Product Code DBI
ProductTina-quant Complement C4 ver.2, Catalog 05991994190
Code Information lot 36870301
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactRoche Customer Support
800-428-2336
Manufacturer Reason
for Recall		Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn August 27, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that this was an expansion of the previous notification sent on September 11, 2019, as new products and lots had been added to the scope of the recall. Customers were asked to do the following: " Discontinue use and discard any remaining affected product in your inventory according to your local waste guidelines. " Refer to the Product Replacement section of the letter for product replacement information. " Complete all sections of the enclosed fax back form and fax or email it according to the instructions on the form even if you are not requesting product replacement. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " File this UMDC for future reference. Roche will replace any of the recalled product remaining in your inventory. To receive replacement product, please complete the response form enclosed with the firm's mailing and fax or email it according to the instructions on the form. 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 this recall.
Quantity in Commerce180 units
DistributionDomestic distribution nationwide.
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 = DBI
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