ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagn...
FDA Recall #Z-0930-2014 — Class II — December 18, 2013
Product Description
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
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.
Recalling Firm
Siemens Healthcare Diagnostics, Inc — East Walpole, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1294 (144 units US)
Distribution
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.
Code Information
Lot # Expiry Date 18998A58 06/09/2014; 21854A58 06/09/2014; 25487A59 09/29/2014.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated