Z-0089-2023Class II

Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material...

Name: Z-0089-2023 Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2022-08-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2022-08-24 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A on 2022-08-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0089-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-24
Posted: 2022-10-14
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
Product code: JHM Colorimetric Method, Lipoproteins
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.
FDA root cause: Under Investigation by firm
Action: Siemens issued an Urgent Medical Device Correction (UMDC) mailed to US affected customers by FedEx beginning on 08/24/2022. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities beginning on 08/24/2022. Letter states: Discontinue use of and discard the lot listed in Table 1. Review your inventory of this lot to determine your laboratory s replacement needs and to provide information to Siemens for reporting to the Authorities. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days to Siemens Healthineers for reporting to the Authorities. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers Technical Support Representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers Technical Support Representative.
Quantity in commerce: 1592 units
Distribution: Nationwide Foreign: Canada
Product codes and lots: UDI-DI : 0084276802043821250BA2022090710464340840 Lot Number: 21250BA Exp. Date: 2022-09-07

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0089-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0089-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-14

Product code JHM

K081300Class IDimension Vista Hdlc Flex Reagent CartridgeSiemens Healthcare Diagnostics / cleared 2008-07-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)