FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma (lithium heparin, potassium EDTA) using the Atellica CH Analyzer SMN: 11097591
- Recall number
- Z-1270-2023
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma (lithium heparin, potassium EDTA) using the Atellica CH Analyzer SMN: 11097591
- Status
- Open, Classified
- Initiated
- 2023-01-27
- Posted
- 2023-08-29
- Terminated
- not on file
- 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 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.
- Quantity
- 11824 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 Kuwait Libya Malaysia Mexico Netherlands New Zealand Norway Oman Pakistan Paraguay Peru Philippines Poland Portugal Qatar Republic Korea Romania Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan, Province of China Thailand Ukraine United Arab Emirates United Kingdom Great Britain Uruguay Vatikancity Vietnam
- Lot, serial or model codes
- UDI: 00630414596495 All Lots
- 510(k) numbers
- ["K133067"]
- PMA numbers
- not on file
- Product code
- CDT
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28