Recall Z-1268-2023 · MRR System, Test, Low Density, Lipoprotein
Siemens Healthcare Diagnostics, Inc.
Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097632
| Date | Aug 29, 2023 (initiated Jan 27, 2023) |
| Status | Open, Classified |
| Reason | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results |
| Root cause | Under Investigation by firm |
| Action | Siemens Issued Urgent Field Notice to US customers ACHC23-01.B.US via FedEx beginning on 01/30/2023. In accordance with outside US country regulations, Siemens in-country personnel for the EU and non-EU regions follow local requirements for contacting their respective National Competent Authorities customers for distribution. and regional reporting to their local competent authorities beginning on 01/27/2023. The UMDC/UFSN provides instructions to all Atellica CH 930 customers to either separate the assays causing carryover by analyzer, if they have multiple analyzers, or by batch testing o |
| Quantity | 8420 units |
| Distribution | Nationwide Foreign: Country Albania Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile China Colombia Croatia Cura¿ao Czech Republic Denmark Ecuador Egypt Finland France Germany Greece Guadeloupe Hong Kong Hungary India Ireland Israel Italy Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982529 | RANDOX DIRECT LDL CHOLESTEROL Randox Laboratories, Ltd., Sep 11, 1998 |