Z-1188-2021Class II

Dimension Vista HDLC - colorimetric method, lipoproteins -

Name: Z-1188-2021 Dimension Vista HDLC - colorimetric method, lipoproteins -
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2021-02-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-02-03 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus)... on 2021-02-03. FDA classified it as Class II and gives the reason as "Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1188-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-02-03
Posted: 2021-03-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease.
Product code: JHM Colorimetric Method, Lipoproteins
Reason for recall: Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridges lot 20062BA.
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Correction (UMDC # VC-21-01.A.US) and Urgent Field Safety Notice (UFSN # VC-21-01.A.OUS) were issued on January 26, 2021 to all Dimension Vista customers who received the Dimension Vista HDLC flex reagent lot 20062BA to notify them of the issue, the potential risk to health, and actions to be taken by the customer.
Quantity in commerce: 4174 devices (Domestic: 2836 devices, Foreign: 1338 devices)
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, WY, and the countries of Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Portugal, SA, Slovakia, Slovenia, Spain, Switzerland.
Product codes and lots: Product: DV HDLC; Lot #: 20062BA; UDI Number: 0084276802043820062BA21030210464340840

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1188-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1188-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-08

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)