Recall Z-1538-2020— Siemens Healthcare Diagnostics, Inc.
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: K053132. Product: ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice. In vitro Diagnostic for the determination of direct bilirubin.. 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 recordK-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 Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice. In vitro Diagnostic for the determination of direct bilirubin.
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.