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Class 2 Device Recall Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) |
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Date Initiated by Firm |
August 28, 2014 |
Date Posted |
October 06, 2014 |
Recall Status1 |
Terminated 3 on March 30, 2015 |
Recall Number |
Z-0024-2015 |
Recall Event ID |
69149 |
510(K)Number |
K051087
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Product Classification |
Calibrator, secondary - Product Code JIT
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Product |
Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista¿ System. |
Code Information |
lot 3JD045, exp. 2014-10-01; lot 4BD064, exp. 2015-02-01; lot 4CD012, exp. 2015-03-01; and lot 4DD065, exp. 2015-05-01. |
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
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Manufacturer Reason for Recall |
Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) shows drift during routine stability monitoring that exceeds our acceptance criteria for drift over the shelf life of this product. Siemens has observed drift from 3% to 12% at MMB concentrations across the assay range. Depending on quality control limits, this drift may not have been d
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FDA Determined Cause 2 |
Process design |
Action |
An Urgent Medical Device Recall notice, dated August 2014, was provided to all Dimension Vista¿ MMB CAL customers who received the affected lots to notify them of the issue, the potential risk to health, and actions to be taken by customers.
Customers were instructed to discard lots 3JD045, 4BD064, 4CD012, and 4DD065, and recalibrate with lot 4FD073. |
Quantity in Commerce |
6562 |
Distribution |
Worldwided distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Canada, Denmark, Germany, Finland, France, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, Slovenia, South Korea, Spain, and Switzerland. |
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 = JIT and Original Applicant = DADE BEHRING, INC.
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