FDA Enforcement
Class III
Terminated
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.
Recall: Z-1217-2017
·
Reported February 22, 2017
Enforcement
- Recall Number
- Z-1217-2017
- Event ID
- 76293
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 22, 2017
- Initiation Date
- May 5, 2016
- Classification Date
- February 16, 2017
- Termination Date
- February 2, 2018
- Address
- 500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States
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
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.
Code Info
Product Lot: 4MD047, 5CD052, 5FD017, 5GD050, 5HD010, 5JD069, 5LD051, 6AD054
Distribution
Distributed throughout the United States
Quantity
24,940.00