Class 2 Device Recall Atellica

• Date Initiated by Firm: November 19, 2019
• Create Date: February 18, 2020
• Recall Status: Terminated on August 30, 2021
• Recall Number: Z-1261-2020
• Recall Event ID: 84413
• 510(K)Number: K081294
• Product Classification: Calibrator, multi-analyte mixture - Product Code JIX
• Product: Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the CardioPhase hsCRP assay
• Code Information: Siemens Material Number (SMN)/REF: Atellica CH:11099412 Lot# 453716 Expiration Date: 2020-01-28 UDI Number: Atellica: (01)00630414597508(10)453716(17)20200128
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 511 Benedict Ave; Tarrytown NY 10591-5005
• For Additional Information Contact: 914-631-8000
• Manufacturer Reason for Recall: Atellica CH: The Atellica CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in vitro diagnostic use in calibrating the hsCRP assay using the Atellica CH Analyzer.
• FDA Determined Cause: No Marketing Application
• Action: On November 19, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: Urgent Medical Device Correction Our records indicate that your facility may have received the following product: Atellica CH 930 Analyzer Reassignment of the Atellica CH High Sensitivity C-Reactive Protein (hsCRP) Calibrator Lot 453716 (Ref/Siemens Material Number  11099412/11099412) ADVIA Chemistry Systems Reassignment of the ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator Lot 453610 (Ref/Siemens Material Number -05006455/10335897) Reason for Correction The purpose of this communication is to inform you of an issue with the product indicated above and provide instructions on actions that your laboratory must take. Siemens has confirmed that the current assigned values for ADVIA Chemistry hsCRP Calibrator Lot 453610 demonstrate a positive bias of approximately 11% for hsCRP patient samples and Quality Control material when compared to the European Reference Material ERM DA474/IFCC for CRP measurement. Depending on the QC concentrations and ranges used by the laboratory, QC may not detect this issue. To correct for the positive bias, the values for ADVIA Chemistry hsCRP Calibrator Lot 453610 have been reassigned to align with reference material ERM DA474/IFCC. The information in Table 2 supersedes the information in the calibrator lot-specific value sheet for hsCRP Calibrator Lot 453610. Refer to Table 2 for the reassigned calibrator values. Patient and Quality Control results are expected to shift approximately -11% when using the reassigned calibrator values for Lot 453610. Based on the negative shift in recovery, it may be necessary to adjust your laboratorys quality control ranges. Refer to Table 3 for representative quality control recovery data. Future commercial calibrator lots will be traceable to this new reference material and will demonstrate comparable performance to the reassig
• Quantity in Commerce: 1306
• Distribution: Worldwide distribution  US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA, WY and countries of UK, CA, PH, MX, VN, TW, TH, IN, CO, AE, AR, AU, BD, BE, BG, BR, CL, CZ, DE, DK, EG, ES, FI, FR, GR, HU, IE, IT, KR, MY, NL, PL, PT, RO, RU, SE, SG.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

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