Recall Z-0929-2014— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-0929-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-18

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2013-12-18, terminated 2016-05-18. It names one FDA 510(k) clearance: K011393. 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. 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-12-18
Terminated: 2016-05-18
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K011393 — RANDOX PHENYTOINRandox Laboratories, Ltd.·cleared 2001-12-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.