Recall Z-0089-2023 ยท JHM Colorimetric Method, Lipoproteins
Siemens Healthcare Diagnostics, Inc.
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
| Date | Oct 14, 2022 (initiated Aug 24, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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 yo |
| Quantity | 1592 units |
| Distribution | Nationwide Foreign: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081300 | DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE Siemens Healthcare Diagnostics, Jul 2, 2008 |