Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0089-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A

Product Classification:

Class II

Date Initiated: August 24, 2022

Date Posted: October 26, 2022

Recall Number: Z-0089-2023

Event ID: 90872

Reason for Recall:

Dimension Vista¿ High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely depressed or elevated result ranging from -90% to 133% may be observed.

Status: Ongoing

Product Quantity: 1592 units

Code Information:

UDI-DI : 0084276802043821250BA2022090710464340840 Lot Number: 21250BA Exp. Date: 2022-09-07

Distribution Pattern:

Nationwide Foreign: Canada

Voluntary or Mandated:

Voluntary: Firm initiated