Recall Z-0928-2022— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0928-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-09

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2022-02-09. It names one FDA 510(k) clearance: K083386. Product: Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644. Reason: Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-02-09
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K083386 — ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)Siemens Healthcare Diagnostics·cleared 2009-04-02

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 Calcium_2 (CA_2), Siemens Material Number 11097644

Reason for recall

Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.

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