Date Initiated by Firm | January 06, 2014 |
Date Posted | February 24, 2014 |
Recall Status1 |
Terminated 3 on May 06, 2015 |
Recall Number | Z-1076-2014 |
Recall Event ID |
67235 |
510(K)Number | K061923 |
Product Classification |
Calibrator, multi-analyte mixture - Product Code JIX
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Product | Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012.
An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System. |
Code Information |
lot 3FD034, exp. 6/17/2014, and lot 3HD012, exp. 9/1/2014. |
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 | Customer Support 800-441-9250 |
Manufacturer Reason for Recall | Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL). |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | A recall notification letter, dated January 2014, was sent to Users. |
Quantity in Commerce | 3496 |
Distribution | Nationwide Distribution. |
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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