Severity
Moderate
Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: Dimension TBI method for the ¿ clinical chemistry syst6em is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma. Dimension Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder diseas
Reported: April 1, 2020 Initiated: February 13, 2020 #Z-1540-2020 1639 US and 747 OUS units
Siemens Healthcare Diagnostics, Inc. issued this FDA Devices recall on April 1, 2020. Classified as Moderate severity (Class II). Approximately 1639 US and 747 OUS units are affected. The recall was issued because: Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-1540-2020) was formally reported on April 1, 2020, with the manufacturer initiating the action on February 13, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Healthcare Diagnostics, Inc. is listed as the recalling firm, operating out of Newark, DE. Federal records indicate 1639 US and 747 OUS units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy Distribution data in the federal record shows the product reached: Nationwide Foreign: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Norway, Pol…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
1639 US and 747 OUS
Related Recalls
6
6 from same agency
Product Description
Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: Dimension TBI method for the ¿ clinical chemistry syst6em is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma. Dimension Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder disease.
Reason for Recall
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 1639 US and 747 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
- Location
- Newark, DE
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1540-2020 |
| Date reported | April 1, 2020 |
| Date initiated | February 13, 2020 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Units affected | 1639 US and 747 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, Roman… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: Dimension TBI method for the ¿ clinical chemistry syst6em is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma. Dimension Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder disease.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 1639 US and 747 OUS.
Why was this product recalled? ▼
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 1, 2020. Severity: Moderate. Recall number: Z-1540-2020.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1540-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
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All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).