Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human ser
FDA device recall Z-1268-2023 · posted 2023-08-29 · Open, Classified
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- MRR
- Quantity affected
- 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 Ecuad
- Date initiated
- 2023-01-27
- Date posted
- 2023-08-29
- Location
- Tarrytown, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RANDOX DIRECT LDL CHOLESTEROL (K982529) | Randox Laboratories, Ltd. | 1998-09-11 |