Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1261-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: November 19, 2019

Date Posted: February 26, 2020

Recall Number: Z-1261-2020

Event ID: 84413

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.

Status: Terminated

Product Quantity: 1306

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated