ADVIA Chemistry CardioPhase High Sensitivity C-Reactive recall
ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the calibration of…
Why was ADVIA Chemistry CardioPhase High Sensitivity C-Reactive recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Siemens Material Number (SMN): ADVIA Chemistry: 10335897 REF: 05006455 Lot# 453610 Expiration Date: 2020-01 UDI Number: ADVIA: (01)00630414526843(10)453610(17)20200128
- Product
- ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the calibration of…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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, CZ, DE, DK, EG, ES, FI, FR, GR, HU, IE, IT, KR, MY, NL, PL, PT, RO, RU, SE, SG.
- Recall date
- February 26, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)