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U.S. Department of Health and Human Services

Class 2 Device Recall Roche OMNI S Analyzer: cobas b 2216Roche OMNI S6 system

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  Class 2 Device Recall Roche OMNI S Analyzer: cobas b 2216Roche OMNI S6 system see related information
Date Initiated by Firm October 31, 2016
Create Date November 29, 2016
Recall Status1 Terminated 3 on September 18, 2017
Recall Number Z-0673-2017
Recall Event ID 75569
510(K)Number K032311  
Product Classification Electrode, ion specific, urea nitrogen - Product Code CDS
Product MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the
Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system
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 Lot Number(s): All lots within shelf life. Expiration Date(s): All 
Recalling Firm/
Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
Manufacturer Reason
for Recall
Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. QC measurement results can be affected as well. This issue is only detectable if comparison result of a second measurement is available. The cause for this issue is an error in the software measurement procedure. In children, decreased urea results can point at inborn disorders or urea cycle. Therefore, false normal urea values could lead to delayed/incorrect diagnosis of such a disorder. Besides the patients most at risk, the risk for the overall patient population with falsely low or high values is considered remote. No severe adverse health effects are expected; but, unnecessary diagnostic measures may be initiated. Falsely normal results may result in further necessary examination not being carried out, with the possibility of a delay in the diagnosis and treatment. A medical risk cannot entirely be excluded.
FDA Determined
Cause 2
Software design
Action Roche sent an Urgent Medical Correction letter dated October 31, 2016, to all affected customers. 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. Actions Required " Use the workaround outlined in this Urgent Medical Device Correction (UMDC) for Urea measurement until the updated software version is available. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " Complete the attached fax form and fax it to 1-877-766-7471. " File this UMDC for future reference. Questions Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272 if you have questions about the information contained in this UMDC.
Quantity in Commerce 97
Distribution Nationwide Distribution including ALCA CO CT FL IL IN KS MD MI MO NC NE NJ NM NY OH OK PA PR SC TX VA and WI
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 = CDS and Original Applicant = ROCHE DIAGNOSTICS CORP.