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Recall Observatory FDA recall evidence

Device 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

Z-0930-2014

December 18, 2013

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 67021
Status
Terminated
Classification
Class II
Quantity
1294 (144 units US)
Official record key
device-enforcement:Z-0930-2014

Official wording

Reason: 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.

Code information: Lot # Expiry Date 18998A58 06/09/2014; 21854A58 06/09/2014; 25487A59 09/29/2014.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.