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U.S. Department of Health and Human Services

Class 2 Device Recall Omni Microelectrode for cobas b221 analyzer

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  Class 2 Device Recall Omni Microelectrode for cobas b221 analyzer see related information
Date Initiated by Firm February 28, 2014
Date Posted April 02, 2014
Recall Status1 Terminated 3 on January 10, 2018
Recall Number Z-1315-2014
Recall Event ID 67549
510(K)Number K032311  
Product Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number:
03111873180 as a part of the following systems:
1. 03337103001, cobas b 221<1>Roche OMNI S1 system

2. 03337111001, cobas b 221<2>Roche OMNI S2 system

3. 03337154001,cobas b 221<6>Roche OMNI S6 system

4. 03337138001, cobas b 221<4>Roche OMNI S4 system

Product Usage: Usage:
Blood Gas and Electrolytes Analyzer c. Classification Name: Fully automated Critical Care Analyzer for the measurement of pH, Blood gases, electrolytes, Hematocrit, hemoglobin, glucose, lactate, urea/BUN, total hemoglobin, Oxygen saturation, oxy - deoxycarboxy and methemoglobin
Code Information all serial numbers
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Todd Siesky
317-521-3911
Manufacturer Reason
for Recall		 Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially cause erroneous pH and/or sodium results. Other Ion parameters are not affected.
FDA Determined
Cause 2		 Device Design
Action Roche Diagnostics Operations sent an Urgent Medical Device Correction letter dated February 27, 2014 via UPS Ground (receipt required) to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the enclosed fax form and fax it to 1-888-345-0253. For questions contact Roche Customer Business Support Center at 1-800-428-5076.
Distribution Worldwide Distribution - USA nationwide including PR and the country of Guam.
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 = and Original Applicant = ROCHE DIAGNOSTICS CORP.
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