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 Initiated
- July 10, 2023
- Posted
- August 28, 2023
- Recall Number
- Z-2472-2023
- Quantity
- 6733 units
- Firm Location
- Tarrytown, NY
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)
Distribution
US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam
Lot / Code Info
Unique Device Identification (UDI): 00630414611037 All Lot Numbers
Root Cause
Under Investigation by firm
Action Taken
Siemens Healthineers issued Urgent Medical Device Correction ACHC23-01.C.US to US affected customers via FedEx beginning on 07/10/2023; and Urgent Field Safety Notice ACHC23-01.C.OUS,OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities beginning on 07/10/2023. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. 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. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. If your laboratory has multiple Atellica CH 930 Analyzers, separate the assays as follows: " Perform testing of TBil_2 on a separate analyzer from Glucose Oxidase (GluO) " Perform testing of LDLC on a separate analyzer from Lipase (Lip) " Perform testing of GGT on a separate analyzer from Magnesium (Mg) " Perform testing of HDLC on a separate analyzer from Uric Acid (UA) If you choose not to or are unable to separate the assays as indicated above, batch testing of GluO, Lip, Mg and UA may be performed. Note: When batch testing impacted assays, GluO, Lip, Mg and UA, an RPC2 wash mitigation must be initiated after completion of tests with the assay causing carryover, TBil_2, LDLC, GGT and HDLC, respectivel