Recall Z-0089-2023— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0089-2023
Creator: U.S. Food and Drug Administration
Published: 2022-08-24

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2022-08-24. It names one FDA 510(k) clearance: K081300. Product: Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A. 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-08-24
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K081300 — DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics·cleared 2008-07-02

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

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.

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