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U.S. Department of Health and Human Services

Class 3 Device Recall Blood Gas and Electrolytes Analyzer

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 Class 3 Device Recall Blood Gas and Electrolytes Analyzersee related information
Date Initiated by FirmSeptember 12, 2014
Date PostedOctober 10, 2014
Recall Status1 Terminated 3 on January 10, 2018
Recall NumberZ-0064-2015
Recall Event ID 69173
510(K)NumberK032311 
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
ProductOmni Micro-electrode/reference electrode for cobas b221 analyzer. 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 Model/Catalog/Part Number: 1. 03337103001 2. 03337111001 3. 03337154001 4. 03337138001 5. 03337120001 6. 03337146001 7. 03337111692 8. 03337138692 9. 03337154692
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactTodd Siesky
317-576-2000 Ext. 249
Manufacturer Reason
for Recall		The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments. In addition, the reference ranges are different when comparing with corresponding ranges listed in the Instructions for Use for the analyzer and the reference literature source.
FDA Determined
Cause 2		Labeling Change Control
ActionThe Urgent Medical Device Correction will be sent via UPS Ground (receipt required) to the consignee list. The Urgent Medical Device Correction will be sent via UPS Ground (receipt required) to the consignee list. Consignees are instructed as follows: " Check the current set of reference values on your cobas b 221 blood gas system and, if appropriate, change the reference ranges accordingly. " If you have not established your own reference ranges, please follow the instructions in the Workaround section of the UMDC or contact the Roche Support Network Customer Support Center.
Quantity in Commerce492 devicees
DistributionNationwide Distribution including Puerto Rico and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, ME, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA and WI.
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 = CHL
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