FDAFDA · Food and drugs·Recall number Z-1217-2017
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.
Published February 22, 2017 · Recall initiated: May 5, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Distributed throughout the United States
- Lot
- Product Lot: 4MD047, 5CD052, 5FD017, 5GD050, 5HD010, 5JD069, 5LD051, 6AD054
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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