Z-1268-2023Class II

Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol...

Name: Z-1268-2023 Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2023-01-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-01-27 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using... on 2023-01-27. FDA classified it as Class II and gives the reason as "Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1268-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-01-27
Posted: 2023-08-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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
Product code: MRR System, Test, Low Density, Lipoprotein
Reason for recall: Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
FDA 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 in commerce: 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 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
Product codes and lots: UDI: 00630414596181 All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1268-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1268-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-29
Z-1269-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-29
Z-1270-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-29
Z-1271-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-29

Product code MRR

K982529Class IRandox Direct Ldl CholesterolRandox Laboratories, Ltd. / cleared 1998-09-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)