Class 2 Device Recall Atellica CH Total Bilirubin_2

• Date Initiated by Firm: July 10, 2023
• Date Posted: August 28, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2471-2023
• Recall Event ID: 92800
• 510(K)Number: K170065
• Product Classification: Enzymatic method, bilirubin - Product Code JFM
• Product: Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531
• Code Information: Unique Device Identification (UDI): 00630414595818 All Lot Numbers
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 511 Benedict Ave; Tarrytown NY 10591-5005
• For Additional Information Contact: SAME; 914-631-8000
• Manufacturer 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), AtellicaCH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and AtellicaCH HDL Cholesterol (HDLC)
• FDA Determined Cause: Under Investigation by firm
• Action: 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
• Quantity in Commerce: 50148 units
• Distribution: US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JFM