Siemens Recalls ADVIA Centaur Phenytoin Calibrator Due to Recovery Changes
Siemens Healthcare Diagnostics is recalling specific lots of ADVIA Centaur Phenytoin Calibrator N because a change in recovery was observed compared to previous lots.
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 and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur Systems Phenytoin Calibrator N (PHTN) 2-pack, SMN 10311391. The recall affects lots CN58 and higher, specifically including lot numbers 19002A58, 19088A58, 21376A58, 25657A59, 26830A59, and 28447A59. The 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.
The recall was initiated because a change in recovery was observed with the ADVIA Centaur Systems Phenytoin assay when using these calibrator lots compared to recoveries using previous Calibrator N lots. The agency classified this recall as Class II.
A total of 1,294 units were distributed, with 296 units distributed in the United States. The product was distributed nationwide in the US and internationally to Argentina, Australia, Brazil, Canada, Colombia, China, Ecuador, Egypt, India, Japan, Korea, Mexico, Saudi Arabia, Singapore, Thailand, and Uruguay. Users should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 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
- Hazard
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 (6)
- Lot # Expiry Date 19002A58 06/09/2014
- 19088A58 06/09/2014
- 21376A58 06/09/2014
- 25657A59 09/29/2014
- 26830A59 09/29/2014
- 28447A59 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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