—#196103

Product

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

FDA product code: JHM — Colorimetric Method, Lipoproteins
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K081300
Affected lot / code info: UDI-DI : 0084276802043821250BA2022090710464340840 Lot Number: 21250BA Exp. Date: 2022-09-07

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Nationwide Foreign: Canada

Timeline

Recall initiated: 2022-08-24
Posted by FDA: 2022-10-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196103. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.