Siemens Recalls ADVIA Chemistry CardioPhase hsCRP Calibrator Due to Accuracy Drift
Siemens Healthcare Diagnostics is recalling 844 units of ADVIA Chemistry CardioPhase hsCRP Calibrator because accuracy has drifted from reference materials, causing high bias in quality control and patient sample recovery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm to patients through inaccurate diagnostic results (high bias), but the source text does not report any specific illnesses, injuries, or fatalities, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 844 units of the ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator. The product is used for in vitro diagnostic purposes to calibrate ADVIA Chemistry systems for the CardioPhase hsCRP assay. The recall is due to the calibrator's accuracy drifting away from reference materials (ERM-DA470/IFCC), which results in a high bias on quality control and patient sample recovery.
The affected product is identified by Siemens Material Number (SMN) 10335897, REF 05006455, Lot# 453610, and an expiration date of 2020-01. The UDI Number is (01)00630414526843(10)453610(17)20200128.
The product was distributed worldwide and nationwide in the United States, including states such as 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, and WY. It was also distributed in countries including the UK, Canada, Philippines, Mexico, Vietnam, Taiwan, Thailand, India, Colombia, UAE, Argentina, Australia, Bangladesh, Belgium, Bulgaria, Brazil, Chile, Czech Republic, Germany, Denmark, Egypt, Spain, Finland, France, Greece, Hungary, Ireland, Italy, South Korea, Malaysia, Netherlands, Poland, Portugal, Romania, Russia, Sweden, and Singapore. Users should stop using the affected calibrators and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- 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.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 844
Distribution
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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