Recall Z-1926-2014— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1926-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-17

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2013-09-17, terminated 2014-08-27. It names one FDA 510(k) clearance: K081683. Product: Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL integrated chemistry system with LOCI module.. Reason: Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-09-17
Terminated: 2014-08-27
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K081683 — LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621Siemens Healthcare Diagnostics·cleared 2008-07-07

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

Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL integrated chemistry system with LOCI module.

Reason for recall

Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration.

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