Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic… — Class II medical device recall Z-1540-2020
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2020-04-01, distributed nationwide. Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
| Recall number | Z-1540-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2020-02-13 |
| Classified | 2020-03-20 |
| Reported by FDA | 2020-04-01 |
| Terminated | 2021-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BD, BE, BG, BH, BR, BS, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KE, KR, KW, LB, LT, LV, MA, MT, MX, MY, NG, NL, NO, NZ, OM, PE, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, UY, VE, VN, ZA |
| UPC / GTIN / UDI-DI | 00842768020544 |
Product
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.