Recall Z-1216-2017— Siemens Healthcare Diagnostics, Inc.
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: K103612. Product: The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. For prescription use only.. Reason: Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Vista Enzyme 2 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 recordK-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 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista 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 Vista Enzyme 2 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.