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U.S. Department of Health and Human Services

Class 3 Device Recall Bilirubin Total Gen.3

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  Class 3 Device Recall Bilirubin Total Gen.3 see related information
Date Initiated by Firm September 11, 2019
Date Posted October 16, 2019
Recall Status1 Open3, Classified
Recall Number Z-0153-2020
Recall Event ID 83806
510(K)Number K131544  
Product Classification Diazo colorimetry, bilirubin - Product Code CIG
Product Cobas c Bilirubin Total Gen.3
Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.
Code Information Lot # 36133801
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Roche Support Network Customer Support Center
800-428-2336
Manufacturer Reason
for Recall		 Due to low Quality Control recovery and invalid Calibration.
FDA Determined
Cause 2		 Under Investigation by firm
Action 1. Discontinue use and discard the remaining affected product in your inventory according to your local waste guidelines. 2. Complete and fax or email the form even if you are not requesting product replacement. 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. An Urgent Medical Device Correction letter dated 12/18/19 was sent to customers regarding the expansion of the recall to include an additional lot of Albumin Gen.2 Reagent. Actions Required " Discontinue use and discard the remaining affected product in your inventory according to your local waste guidelines. " Complete the attached fax form (TP-00848) and fax or email it according to the instructions on the form even if you are not requesting product replacement. " 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 1-800-428-2336 if you have questions about the information contained in this UMDC.
Quantity in Commerce 2,304 units
Distribution US Nationwide distribution including the states of AL, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA and WI. Updated as of 12/20/19 to include the following additional US states: CO.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CIG and Original Applicant = Roche Diagnostics
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