Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0089-2023

August 24, 2022

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 90872
Status
Ongoing
Classification
Class II
Quantity
1592 units
Official record key
device-enforcement:Z-0089-2023

Official wording

Reason: 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.

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

Distribution pattern: Nationwide Foreign: Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.