| Class 2 Device Recall Siemens Atellica CH Direct Bilirubin_2 assay | |
Date Initiated by Firm | February 13, 2020 |
Create Date | March 20, 2020 |
Recall Status1 |
Terminated 3 on April 23, 2021 |
Recall Number | Z-1536-2020 |
Recall Event ID |
85037 |
510(K)Number | K053132 |
Product Classification |
Enzymatic method, bilirubin - Product Code JFM
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Product | Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin
SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice. |
Code Information |
Lot # UDI Number 190273 (01)00630414595801(10)190273(17)20201203 190187 (01)00630414595801(10)190187(17)200820 190120 (01)00630414595801(10)190120(17)200521 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 500 Gbc Dr Newark DE 19702-2466
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For Additional Information Contact | SAME 800-441-9250 |
Manufacturer Reason for Recall | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
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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. |
Quantity in Commerce | 577 US and OUS 2617 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = JFM
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