Z-1537-2020Class II

Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN...

Name: Z-1537-2020 Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2020-02-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-02-13 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on 2020-02-13. FDA classified it as Class II and gives the reason as "Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1537-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-13
Posted: 2020-03-20
Terminated: 2021-04-23
Recalling firm: Siemens Healthcare Diagnostics Inc.
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).
Product code: JFM Enzymatic Method, Bilirubin
Reason for recall: Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
FDA root cause: 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: 2323 US and 8193 OUS
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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1537-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1536-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-20
Z-1537-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-20
Z-1538-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-20
Z-1539-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-20
Z-1540-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-20
Z-1541-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-20

Product code JFM

K053131Class IIWako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801, 990-23191Wako Chemicals USA, Inc. / cleared 2005-12-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)