Device product
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.
Z-1260-2020
Product summary
- Event
- Event 84413
- Status
- Terminated
- Classification
- Class II
- Quantity
- 844
- Official record key
device-enforcement:Z-1260-2020
Official wording
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.
Code information: Siemens Material Number (SMN): ADVIA Chemistry: 10335897 REF: 05006455 Lot# 453610 Expiration Date: 2020-01 UDI Number: ADVIA: (01)00630414526843(10)453610(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.
Derived failure modes
-
Unknown
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.