Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic for the determination of total…
Medical device recall Z-1541-2020. Published in FDA’s Enforcement Report on Apr 1, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 1, 2020. Copied from openFDA on Oct 20, 2026.
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10445146 Product Usage: Dimension Vista TBIL method is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma on the Dimension Vista¿ System. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder disease.
How much: “N/A”, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Number/UDI: Lot # UDI Number EB1008 0842768020544EB100821010810444957840 FA0365 0842768020544FA036520123010444957840 FA0346 0842768020544FA034620121110444957840 GB0326 00842768020544GB032620112110444957840 EA0318…
Every code shown here, 1,993 characters
Lot Number/UDI: Lot # UDI Number 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 20006AB 0084276801571720006AB21010510445146840 19336BB 0084276801571719336BB20120110445146840 19325AB 0084276801571719325AB20112010445146840 19325AA 0084276801571719325AA20112010445146840 19294BC 0084276801571719294BC20102010445146840 19291BA 0084276801571719291BA20101710445146840 19262BD 0084276801571719262BD20091810445146840 19238BA 0084276801571719238BA20082510445146840 19220AA 0084276801571719220AA20080710445146840 19207BA 0084276801571719207BA20072510445146840 19206BA 0084276801571719206BA20072410445146840 19162BC 0084276801571719162BC20061010445146840 19155AB 0084276801571719155AB20060310445146840 19128BB 0084276801571719128BB20050710445146840…
FDA’s list runs to 2,180 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 13, 2020.
- FDA classified it on Mar 20, 2020.
- FDA’s Enforcement Report published it on Apr 1, 2020.
- FDA terminated it on Apr 23, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Siemens Healthcare Diagnostics, Inc., of Newark, DE.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,180 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.