FDAFDA · Food and drugs·Recall number Z-0089-2023
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
Published October 26, 2022 · Recall initiated: August 24, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Nationwide Foreign: Canada
- Lot
- UDI-DI : 0084276802043821250BA2022090710464340840 Lot Number: 21250BA Exp. Date: 2022-09-07
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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