Z-1261-2020Class II

Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator -

Name: Z-1261-2020 Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator -
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2019-11-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-11-19 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic use in the calibration of ADVIA Chemistry systems... on 2019-11-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1261-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-19
Posted: 2020-02-18
Terminated: 2021-08-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
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
Product code: JIX Calibrator, Multi-Analyte Mixture
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.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: Siemens Material Number (SMN)/REF: Atellica CH:11099412 Lot# 453716 Expiration Date: 2020-01-28 UDI Number: Atellica: (01)00630414597508(10)453716(17)20200128

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1261-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1260-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-18
Z-1261-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-18

Product code JIX

K081294Class IIAdvia Chemistry Cardiophase High Sensitivity C-Reactive Protein (Hscrp), CalibratorsSiemens Healthcare Diagnostics, Inc. / cleared 2008-07-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)