Recall Z-1539-2020— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1539-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-13

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2020-02-13, terminated 2021-04-23. It names one FDA 510(k) clearance: K170065. Product: 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 total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder block. A total bilirubin measurement in newborn infants is intended to aid in indicating the risk of bilirubin encephalopathy (kernicterus).. Reason: Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy.

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-02-13
Terminated: 2021-04-23
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K170065 — ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)Siemens Healthcare Diagnostics, Inc.·cleared 2017-03-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder block. A total bilirubin measurement in newborn infants is intended to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.