Recall Z-1970-2013— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-1970-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-28

Class III · Terminated

Class III FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2013-06-28, terminated 2014-07-25. It names one FDA 510(k) clearance: K961510. Product: ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3, T3, T4, Tup, FT4, THEO2.. Reason: Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay..

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class III
Status: Terminated
Initiated: 2013-06-28
Terminated: 2014-07-25
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K961510 — ACS FRT4 IMMUNOASSAYCiba Corning Diagnostics Corp.·cleared 1996-06-17

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 Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3, T3, T4, Tup, FT4, THEO2.

Reason for recall

Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay.

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