Siemens Recalls ADVIA Centaur Phenytoin Calibrator Due to Recovery Changes
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Phenytoin Calibrator N lots due to observed changes in assay recovery.
What this means for you
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, and the source text describes a change in assay recovery without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling specific lots of ADVIA Centaur Systems Phenytoin Calibrator N. The recall involves 1,294 units distributed nationwide in the United States and internationally to 16 countries, including Argentina, Australia, Brazil, Canada, and China.
The recall was initiated because a change in recovery was observed with the ADVIA Centaur Systems Phenytoin assay when using these specific calibrator lots compared to previous lots. The affected lots are identified by the following lot numbers and expiry dates: 18998A58 (06/09/2014), 21854A58 (06/09/2014), and 25487A59 (09/29/2014).
This product is intended for in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems. Users should stop using the affected calibrator lots and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
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)
- Lot # Expiry Date 18998A58 06/09/2014
- 21854A58 06/09/2014
- 25487A59 09/29/2014.
Distribution
Distributed nationwide across the United States.
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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