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U.S. Department of Health and Human Services

Class 2 Device Recall Cobas u 601 urinalysis test system

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  Class 2 Device Recall Cobas u 601 urinalysis test system see related information
Date Initiated by Firm October 18, 2021
Create Date November 18, 2021
Recall Status1 Terminated 3 on May 31, 2023
Recall Number Z-0266-2022
Recall Event ID 88879
510(K)Number K183432  
Product Classification Automated urinalysis system - Product Code KQO
Product Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the cobas u 601 urine analyzer and the cobas u pack. The cobas u 601 urine analyzer when used with the cobas u pack is a fully automated urinalysis system intended for the in vitro qualitative or semi-quantitative determination of urine analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, color and erythrocytes, as well as clarity.
Code Information UDI 04015630932252
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Roche Support Network Support Center
800-428-2336
Manufacturer Reason
for Recall		 A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L and above. No interference of Nitrite results was observed at creatinine levels up to 9,000 mg/L.
FDA Determined
Cause 2		 Software design
Action On October 18, 2021, the firm, Roche, sent "URGENT MEDICAL DEVICE CORRECTION" letters to affected consignees. Customers were notified of the potential for false negative nitrite test results with elevated endogenous creatinine concentrations. Customers were provided with an amended cobas u pack method sheet that provides the updated interference claim for endogenous creatinine. Nitrite testing is commonly included in the process of diagnosing urinary tract infections. In case of false negative nitrite results, particularly in asymptomatic patients or patient with nonspecific symptoms, further diagnostic measures in urine might be skipped, resulting in an increased potential risk for disease progression and complications of UTI. Actions required: - Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. - Review the updated cobas u pack method sheet included with the letter and update your laboratory's procedures, if needed. - Complete and return the customer response form via email to roche6051@sedgwick.com. - File the recall notice 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 the information contained in this UMDC.
Quantity in Commerce 636
Distribution US Nationwide distribution.
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 = KQO and Original Applicant = Roche Diagnostics
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