—#179950

Product

Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates using the Atellica CH Analyzer. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder block, A total bilirubin measurement in newborn infants is intended to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

FDA product code: JFM — Enzymatic Method, Bilirubin
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K053131
Affected lot / code info: Lot # UDI Number 190028 (01)00630414595818(10)190028(17)20200420 190063 (01)00630414595818(10)190063(17)20200601 190112 (01)00630414595818(10)190112(17)20200810 190152 (01)00630414595818(10)190152(17)20201005 190205 (01)00630414595818(10)190205(17)20201221 190235 (01)00630414595818(10)190235(17)20210118 190265 (01)00630414595818(10)190265(17)20210301

Why it was recalled

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr, Newark, Delaware 19702-2466

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2020-02-13
Terminated: 2021-04-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179950. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.