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.
Action Details
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.
Distribution Pattern
Nationwide
Foreign: Canada
Code Information / Serial Numbers
UDI-DI : 0084276802043821250BA2022090710464340840
Lot Number: 21250BA
Exp. Date: 2022-09-07
Public Record Disclaimer
This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.