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U.S. Department of Health and Human Services

Class 2 Device Recall cobas b 2216Roche OMNI S6 system

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  Class 2 Device Recall cobas b 2216Roche OMNI S6 system see related information
Date Initiated by Firm February 22, 2018
Date Posted May 03, 2018
Recall Status1 Terminated 3 on November 15, 2019
Recall Number Z-1612-2018
Recall Event ID 79676
510(K)Number K032311  
Product Classification Electrode, ion specific, potassium - Product Code CEM
Product cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692

The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.
Code Information Catalog numbers: 3337154001 and 3337154692 UDI: 04015630018345
Recalling Firm/
Manufacturer		 Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Roche Support Network Customer Support Center
800-526-2272
Manufacturer Reason
for Recall		 The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
FDA Determined
Cause 2		 Software design
Action ROCHE sent an Urgent Medical Device Correction Letter dated February 22, 2018, via UPS to affected customers. Customers were instructed to complete the following: " 1) Use the Return to Setup and Exit buttons to ensure execution of scheduled AutoQC measurements as described in this Urgent Medical Device Correction (UMDC); 2) Check to see if the next scheduled AutoQC measurement is performed to ensure the AutoQC scheduler is working as expected; 3) If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site; 4) Complete the attached fax form (TP-00146) and fax it to 1-844-491-7776 or scan and email to roche7570@stericycle.com; 5) File this UMDC for future reference. Customers with questions should contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272.
Quantity in Commerce 1026 total products
Distribution USA ( 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 = CEM and Original Applicant = ROCHE DIAGNOSTICS CORP.
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