Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1539-2020 — ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma of adults and neonates on the ADVIA¿ Chemistry systems. Measurement of to

U.S. FDA — Device Enforcement · United States · 2020-02-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1539-2020
Date of alert: 2020-02-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Siemens Healthcare Diagnostics, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00630414513072

Reported risk: Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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