Recall Z-2430-2020— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2430-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-05

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2020-06-05, terminated 2021-11-18. It names one FDA 510(k) clearance: K050374. Product: ADVIA Chemistry Calibrator. Reason: Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-06-05
Terminated: 2021-11-18
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K050374 — ADVIA IMS LITHIUM ASSAYBayer Healthcare, LLC·cleared 2005-06-15

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 Calibrator

Reason for recall

Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.

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