FDA Enforcement
Class II
Ongoing
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin Test Code: LDLC Siemens Material Number (SMN): 11537214
Recall: Z-2472-2023
·
Reported September 6, 2023
Enforcement
- Recall Number
- Z-2472-2023
- Event ID
- 92800
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 6, 2023
- Initiation Date
- July 10, 2023
- Classification Date
- August 28, 2023
- Address
- 511 Benedict Ave, N/A, Tarrytown, NY, 10591-5005, United States
Description
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin Test Code: LDLC Siemens Material Number (SMN): 11537214
Reason
Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿ CH Total Bilirubin_2 (TBil_2), Atellica¿ CH LDL Cholesterol (LDLC), Atellica¿ CH Gamma-Glutamyl Transferase (GGT) and Atellica¿ CH HDL Cholesterol (HDLC)
Code Info
Unique Device Identification (UDI): 00630414611037 All Lot Numbers
Distribution
US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam
Quantity
6733 units