Recall Z-0581-2020— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0581-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-23

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2019-09-23, terminated 2022-07-06. It names one FDA 510(k) clearance: K151767. Product: Atellica CH 930 Analyzer. Reason: Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-09-23
Terminated: 2022-07-06
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K151767 — Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP CalibratorSiemens Healthcare Diagnostics, Inc.·cleared 2015-12-11

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

Atellica CH 930 Analyzer

Reason for recall

Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.

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