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U.S. Department of Health and Human Services

Class 3 Device Recall Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator

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  Class 3 Device Recall Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator see related information
Date Initiated by Firm October 10, 2012
Date Posted March 25, 2013
Recall Status1 Terminated 3 on January 08, 2014
Recall Number Z-0988-2013
Recall Event ID 63494
510(K)Number K061818  
Product Classification Calibrator, secondary - Product Code JIT
Product Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator

The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System.
Code Information Lot 2AD052 Catolog KC330
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Avenue
Tarrytown NY 10591-5097
For Additional Information Contact Customer Support
302-631-6311
Manufacturer Reason
for Recall		 Correlation slope bias and accuracy shift
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens sent a Urgent Medical Device Correction letter dated October 16, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to calibrate with newer lots of Dimension Vista(R) ALP Calibrator as they become available, beginning with lot 2GD011. Customers were also asked to discontinue use and discard any remaining inventory of lot 2AD052. Customers further instructed to complete the attached response form and fax to (302) 631-8467, to indicate they had received the information and to facilitate their no charge replacement. Further questions please call (302) 631-6311.
Quantity in Commerce 1985 cartons
Distribution Nationwide distribution: USA including Puerto Rico and the states of AL, OH, MO, GA, IL, CT, IA, SC, VA, TX, FL, NY, NC, CA, NM, AZ, CA, MI, NJ, PR, MS, NE, WV, PA, MT, MA, MD, KS, NH, TN, VT, LA, CO, ID, WA, NH, DE and OR.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = JIT and Original Applicant = DADE BEHRING, INC.
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