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U.S. Department of Health and Human Services

Class 2 Device Recall Tinaquant CReactive Protein Gen.3

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 Class 2 Device Recall Tinaquant CReactive Protein Gen.3see related information
Date Initiated by FirmNovember 06, 2020
Create DateDecember 17, 2020
Recall Status1 Terminated 3 on October 18, 2024
Recall NumberZ-0634-2021
Recall Event ID 86745
510(K)NumberK083444 
Product Classification System, test, c-reactive protein - Product Code DCN
ProductTina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.
Code Information CRPL3 - lot 42402301
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactRoche Support Network Customer Support Center
800-428-2336
Manufacturer Reason
for Recall		Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.
FDA Determined
Cause 2		Process control
ActionOn November 6, 2020, the firm mailed customers Urgent Medical Device Correction letters. Customers were informed that the present communication serves as an update to previous UMDCs sent on 9/11/2019, 12/18/2019, and 8/27/2020, in that it includes the new product and lot number listed above. Customer Instructions: " Discontinue use and discard any remaining affected product in your inventory according to your local waste guidelines. " Refer to the Product Replacement section on page 2 of the UMDC for product replacement information. " Complete all sections of the enclosed faxback form (TP-01128) 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. 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 Commerce699 units
DistributionUS Nationwide distribution including in the states of AL, CA, FL, GA, HI, IA, IL, IN, KY, MA, MD, MI, MN, MO, NJ, NY, OH, PA, SC, TN, TX, VA.
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 = DCN
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