PlainRecalls
FDA Devices Moderate 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

Reported: September 6, 2023 Initiated: July 10, 2023 #Z-2472-2023

Product 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 for Recall

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)

Details

Units Affected
6733 units
Distribution
US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam
Location
Tarrytown, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 6733 units.
Why was this product recalled?
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)
Which agency issued this recall?
This recall was issued by the FDA Devices on September 6, 2023. Severity: Moderate. Recall number: Z-2472-2023.