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
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics, Inc. has recalled the Atellica CH High Sensitivity C-Reactive Protein Calibrator, a medical device used in laboratories to calibrate diagnostic equipment. The recalled product is identified by Siemens Material Number 11099412, Lot #453716, with an expiration date of January 28, 2020, and 1,306 units were distributed worldwide across numerous U.S. states and countries including the United Kingdom, Canada, Philippines, Mexico, Vietnam, Taiwan, Thailand, India, Colombia, United Arab Emirates, and various European nations.
The recall notice does not specify the reason for the recall or any health hazard associated with the product. The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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. Quantity: 1306 Lot/code info: Siemens Material Number (SMN)/REF: Atellica CH:11099412 Lot# 453716 Expiration Date: 2020-01-28 UDI Number: Atellica: (01)00630414597508(10)453716(17)20200128
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.