The Enzyme 2 Calibrator is an in vitro diagnostic recall
The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate…
Why was The Enzyme 2 Calibrator is an in vitro diagnostic recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: 4MD048, 5DD026, 5ED071, 5GD004, 5JD058, 5LD061
- Product
- The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 13,147 units
- Distribution
- Distributed throughout the United States
- Recall date
- February 22, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)