Recall Z-0173-2014— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-0173-2014
Creator: U.S. Food and Drug Administration
Published: 2013-08-16

Class III · Terminated

Class III FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2013-08-16, terminated 2014-02-13. It names one FDA 510(k) clearance: K020217. Product: ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.. Reason: PTH Calibrator packaged with only high calibrator..

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class III
Status: Terminated
Initiated: 2013-08-16
Terminated: 2014-02-13
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K020217 — ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAYBayer Diagnostics Corp.·cleared 2002-03-15

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 Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.

Reason for recall

PTH Calibrator packaged with only high calibrator.

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