Siemens Healthcare Diagnostics, Inc. Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum and plasma (lithium heparin, sodium heparin, potassium EDTA) using the Atellica CH Analyzer. SMN: 11537222 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum and plasma (lithium heparin, sodium heparin, potassium EDTA) using the Atellica CH Analyzer. SMN: 11537222
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
UDI: 00630414610955 All Lots
Products Sold
UDI: 00630414610955 All Lots
Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglyceri due to Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (M. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
Recommended Action
Per FDA guidance
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 of Mg. In addition, the UMDC and UFSN indicates that SW v1.27 and higher will correct this issue. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director. Perform the instructions provided in the Additional Information section. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. 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. Contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026