Siemens ADVIA Chemistry Systems Drug Calibrator I Recalled for Incorrect Values
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018, due to incorrect calibrator values for Phenytoin 2 and Phenobarbital 2 assays.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect calibration values which could lead to inaccurate diagnostic results, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 657 units of ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018. The product is used for in vitro diagnostic calibration of Phenobarbital 2 (PHNB_2), Phenytoin 2 (PHNY_2), and Theophylline 2 (THEO_2) methods on ADVIA Chemistry systems.
The recall was initiated because incorrect calibrator lot values were assigned for the Phenytoin 2 and Phenobarbital 2 assays. This error resulted from a miscalculation of the calibrator values. The affected units were distributed nationwide in the United States and internationally to Canada and Mexico.
The recalled product has Material Number 10376770 and an expiration date of April 2015. Users should stop using the affected lot and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and Theophylline_2 (THEO_2) methods on the ADVIA Chemistry systems. System Information: (For Information Only) The ADVIA Chemistry…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 657
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Material Number 10376770
- Lot Number 3JD018
- Expiration: April 2015
Distribution
Distributed nationwide across the United States.
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