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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Dimension Vista Total Bilirubin Flex reagent cartridge

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  Class 2 Device Recall Siemens Dimension Vista Total Bilirubin Flex reagent cartridge see related information
Date Initiated by Firm February 13, 2020
Create Date March 20, 2020
Recall Status1 Terminated 3 on April 23, 2021
Recall Number Z-1541-2020
Recall Event ID 85037
510(K)Number K061719  
Product Classification Diazo colorimetry, bilirubin - Product Code CIG
Product Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge
-In vitro Diagnostic for the determination of total bilirubin.
SMN: 10445146

Product Usage: Dimension Vista TBIL method is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma on the Dimension Vista¿ System. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder disease.
Code Information Lot Number/UDI: Lot # UDI Number EB1008 0842768020544EB100821010810444957840 FA0365 0842768020544FA036520123010444957840 FA0346 0842768020544FA034620121110444957840 GB0326 00842768020544GB032620112110444957840 EA0318 00842768020544EA031820111310444957840 GD0309 00842768020544GD030920110410444957840 FB0298 00842768020544FB029820102410444957840 GA0284 00842768020544GA028420101010444957840 GB0275 00842768020544GB027520100110444957840 GD0274 00842768020544GD027420093010444957840 FB0263 00842768020544FB026320091910444957840 GA0256 00842768020544GA025620091210444957840 GB0242 00842768020544GB024220082910444957840 FD0226 00842768020544FD022620081310444957840 EB0221 00842768020544EB022120080810444957840 EB0192 00842768020544EB019220071010444957840 ED0191 00842768020544ED019120070910444957840 FC0170 00842768020544FC017020061810444957840 FA0169 00842768020544FA016920061710444957840 GA0157 00842768020544GA015720060510444957840 BB0134 00842768020544BB013420051310444957840 GB0122 00842768020544GB012220050110444957840 GA0121 00842768020544GA012120043010444957840 GD0113 00842768020544GD011320042210444957840 GD0093 00842768020544GD009320040210444957840 GD0086 00842768020544GD008620032610444957840 FB0067 00842768020544FB006720030710444957840 GB0059 00842768020544GB005920022810444957840 EA0045 00842768020544EA004520021410444957840 20006AB 0084276801571720006AB21010510445146840 19336BB 0084276801571719336BB20120110445146840 19325AB 0084276801571719325AB20112010445146840 19325AA 0084276801571719325AA20112010445146840 19294BC 0084276801571719294BC20102010445146840 19291BA 0084276801571719291BA20101710445146840 19262BD 0084276801571719262BD20091810445146840 19238BA 0084276801571719238BA20082510445146840 19220AA 0084276801571719220AA20080710445146840 19207BA 0084276801571719207BA20072510445146840 19206BA 0084276801571719206BA20072410445146840 19162BC 0084276801571719162BC20061010445146840 19155AB 0084276801571719155AB20060310445146840 19128BB 0084276801571719128BB20050710445146840 19094BA 0084276801571719094BA20040310445146840 19084BA 0084276801571719084BA20032410445146840 19071AA 0084276801571719071AA20031110445146840 19060BB 0084276801571719060BB20030110445146840 
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr
Newark DE 19702-2466
For Additional Information Contact SAME
800-441-9250
Manufacturer Reason
for Recall		 Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens Healthineers issued Urgent Medical Device Correction (UMDC # ACHC-20-02.A.US, ACHC-20-02.A.US.AC, ACHC-20-02.A.US.DM, ACHC-20-02.A.US.DV) and Urgent Field Safety Notice (UFSN # ACHC-20-02.A.OUS, ACHC-20-02.A.OUS.AC, ACHC-20-02.A.OUS.DM, ACHC-20-02.A.OUS.DV) on February 13, 2020 to all Atellica CH, ADVIA CH, Dimension, and Dimension Vista customers to inform them of the issue, the potential risk to health, and actions to be taken by the customer. Customers were instructed to:Review the information on eltrombopag interference (ADVIA CH and Atellica CH bilirubins) or use of total bilirubin assay is not recommended for patients on eltrombopag therapy (Dimension and Dimension Vista). Review the letter with their Medical Director Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days. If they have received any complaints of illness or adverse events associated with the product, immediately contact their local Siemens Customer Care Center or their local Siemens Technical Support Representative.
Distribution Nationwide Foreign: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Azerbaijan, Bahamas, Bahrain, Bangladesh, Benin, Bosnia Herzegovina, Botswana, Brazil, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Congo, Ecuador, Egypt, French Guinea, Georgia, Guadeloupe, Hong Kong, India, Indonesia, Iraq, Iran, Israel, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Lesotho, Libya, Macedonia, Malawi, Malaysia, Mali, Mexico, Montenegro, Morocco, Mozambique, Myanmar, New Zealand, Nigeria, Oman, Pakistan, Peru, Philippines, Qatar, Republic if Yemen, Republic Korea, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, South Africa, Swaziland, Taiwan, Tanzania, Thailand, Tunisia, Turkmenistan, United Arab Emirates, Ukraine, Uruguay, Venezuela, Vietnam, Zimbabwe
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 = CIG and Original Applicant = DADE BEHRING, INC.
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