CLASS II Device recall · Reported 1 Apr 2020 · FDA Enforcement Report
Dimension Total Bilirubin Flex reagent cartridge -In vitro recalled
Siemens Healthcare Diagnostics is recalling Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the, distributed nationwide in the US. The recall was initiated on 13 Feb 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1540-2020
- FDA event ID
- 85037
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Feb 2020
- FDA classified
- 20 Mar 2020
- Reported
- 1 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 13 Feb 2020 | Recall initiated by company | |
| 20 Mar 2020 | Classified by FDA | +36 days |
| 1 Apr 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
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
Questions about this recall
Why was it recalled?
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Which lots are affected?
Lot Number/UDI: 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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 85037This product is part of a recall event; the main page for the event is Advia Chemistry Total Bilirubin_2 assay- SMN recalled.
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