Reported Apr 1, 2020 · Terminated
Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN:…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr · Newark, DE · 19702-2466
Is this the product you have?
- Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin
- SMN10444957
- Product UsageDimension 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
- Lot codes and dates
- Lot Number/UDIEB1008 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
- Amount recalled
- 1639 US and 747 OUS
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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