Recall Z-1217-2017— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1217-2017
Creator: U.S. Food and Drug Administration
Published: 2016-05-05

Class III · Terminated

Class III FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2016-05-05, terminated 2018-02-02. It names one FDA 510(k) clearance: K103836. Product: The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry system. For prescription use only.. Reason: Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Enzyme II calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class III
Status: Terminated
Initiated: 2016-05-05
Terminated: 2018-02-02
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K103836 — ENZYME II CALIBRATORSiemens Healthcare Diagnostics, Inc.·cleared 2011-02-16

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

The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry system. For prescription use only.

Reason for recall

Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Enzyme II calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.

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