Recall Z-1260-2020 ยท JIX Calibrator, Multi-Analyte Mixture
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Nov 19, 2019 |
| Status | Terminated |
| Reason | 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. |
| 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 |
| Quantity | 844 |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081294 | ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS Siemens Healthcare Diagnostics, Inc., Jul 29, 2008 |