Date Initiated by Firm |
August 18, 2014 |
Date Posted |
September 30, 2014 |
Recall Status1 |
Terminated 3 on February 02, 2015 |
Recall Number |
Z-2720-2014 |
Recall Event ID |
69063 |
510(K)Number |
K061838
|
Product Classification |
Calibrator, multi-analyte mixture - Product Code JIX
|
Product |
Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081.
The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on the Dimension Vista¿ System. |
Code Information |
lot 3GM081, exp. 07-01-2014 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 500 Gbc Dr Ms 514 PO BOX 6101 Newark DE 19702-2466
|
For Additional Information Contact |
Customer Support 800-441-9250
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Manufacturer Reason for Recall |
Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension Vista® CHEM 1 CAL, lot 3GM081. Investigation by Siemens confirms that QC and patient samples under-recovers MG by 0.25 mg/dL [0.10 mmol/L] across the assay range following calibration with 3GM081.
|
FDA Determined Cause 2 |
Process design |
Action |
Siemens sent an Urgent Medical Device Dorrection letter, dated August 2014, to all affected consignees. The letter identified the product, the problem, and the actions to be taken. Consignees were instructed if they still have an active calibration of MG with this lot of CHEM 1 CAL, they should immediately calibrate MG with an alternate lot of CHEM 1 CAL. Consigness were instructed to retain the letter with their laboratory records, and to forward the letter to those who may have received the affected product.
Customers with questions were instructed to contact their Siemens Customer Care Center - Techhnical Solutions or their local Siemens technical support representative. |
Quantity in Commerce |
9769 Total (6000 US) |
Distribution |
Worldwide Distribution - USA (Nationwide) and Internationally to Australia
Austria
Belgium
Canada
Czech Republic
Finland
France
Germany
Great Britain
Italy
Japan
Netherlands
New Zealand
Norway
Portugal
Slovak Republic
Slovenia
South Korea
Spain
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 = JIX and Original Applicant = DADE BEHRING, INC.
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