Recall record at a glance
| Official record | Z-1216-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Report date | Feb 22, 2017 |
| Recall initiation date | May 5, 2016 |
| Quantity | 13,147 units |
| Location | Newark, DE, United States |
Official 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.
Why the product was 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.
Distribution information
Distributed throughout the United States
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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