Date Initiated by Firm | May 05, 2016 |
Create Date | February 16, 2017 |
Recall Status1 |
Terminated 3 on February 02, 2018 |
Recall Number | Z-1216-2017 |
Recall Event ID |
76293 |
510(K)Number | K103612 |
Product Classification |
Calibrator, multi-analyte mixture - Product Code JIX
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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. |
Code Information |
Lot Number: 4MD048, 5DD026, 5ED071, 5GD004, 5JD058, 5LD061 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 500 Gbc Dr Ms 514 PO BOX 6101 Newark DE 19702-2466
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For Additional Information Contact | 800-441-9250 |
Manufacturer 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. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Siemens mailed an Urgent Medical Device Notification letter to all affected customers on May 10, 2016. The notice provided information on actions to be taken by the customer to work around the issue.
For further questions, please call (800) 441-9250. |
Quantity in Commerce | 13,147 units |
Distribution | Distributed throughout the United States |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JIX
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