Recall Z-0330-2022— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0330-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-15

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2021-10-15, terminated 2024-05-13. It names 2 FDA 510(k) clearances: K143720, K051087. Product: Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS). Reason: Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays.

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-10-15
Terminated: 2024-05-13
Firm location: Newark, DE, United States

510(k) clearances named in this recall

2 on FDA's record

K143720 — Dimension Vista MMB AssaySiemens Healthcare Diagnostics·cleared 2015-09-18
K051087 — DIMENSION VISTA INTEGRATED SYSTEMDade Behring, Inc.·cleared 2005-07-11

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

Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS)

Reason for recall

Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays

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