CLASS II Device recall · Reported 12 Feb 2014 · FDA Enforcement Report
Advia Centaur¿ Systems Phenytoin Calibrator N recalled
Siemens Healthcare Diagnostics is recalling Advia Centaur¿ Systems Phenytoin Calibrator N ( Phtn) Smn 10311391 For in vitro, distributed nationwide in the US. The recall was initiated on 18 Dec 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0929-2014
- FDA event ID
- 67021
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Dec 2013
- FDA classified
- 4 Feb 2014
- Reported
- 12 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 18 Dec 2013 | Recall initiated by company | |
| 4 Feb 2014 | Classified by FDA | +48 days |
| 12 Feb 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia,Brazil,Canada, Columbia, China, Ecuador, Egypt, India, Japan, Korea, Mexico, Saudi Arabia,Singapore, Thailand, and Uruguay.
Questions about this recall
Why was it recalled?
ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots.
Which lots are affected?
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.
Where was it sold?
Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia,Brazil,Canada, Columbia, China, Ecuador, Egypt, India, Japan, Korea, Mexico, Saudi Arabia,Singapore, Thailand, and Uruguay.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 67021| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Advia Centaur¿ Systems Phenytoin Calibrator N recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
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