ADVIA Chemistry CardioPhase 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 is recalling ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator used for in vitro diagnostic calibration. The calibrator's accuracy has drifted away from reference materials (ERM-DA470/IFCC), causing high bias on quality control and patient sample recovery results. The affected product is Siemens Material Number 10335897 (REF: 05006455) with Lot# 453610 and expiration date January 2020. A total of 844 units were distributed worldwide, including across the United States and numerous countries in Europe, Asia, Latin America, the Middle East, Africa, and Oceania.
The recall was issued due to the calibrator accuracy drift affecting test result reliability. The source document does not specify a remedy or recommended consumer action.
Written by software from the official notice below. Not reviewed by a lawyer.
Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient sample recovery.
Reason for recall: Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient sample recovery. 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: 844 Lot/code info: Siemens Material Number (SMN): ADVIA Chemistry: 10335897 REF: 05006455 Lot# 453610 Expiration Date: 2020-01 UDI Number: ADVIA: (01)00630414526843(10)453610(17)20200128
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.