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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista Calcium (CA) Flex Reagent cartridge

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  Class 2 Device Recall Dimension Vista Calcium (CA) Flex Reagent cartridge see related information
Date Initiated by Firm January 30, 2018
Create Date April 27, 2018
Recall Status1 Terminated 3 on May 16, 2019
Recall Number Z-1540-2018
Recall Event ID 79593
510(K)Number K061792  
Product Classification Cresolphthalein complexone, calcium - Product Code CIC
Product Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160

The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.
Code Information Lot # 17171BD, UDI # (UDI) 0084276801561817171BD18062010445160 EXP. 06-20-2018
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
Po Box 6101
Newark DE 19702-2466
For Additional Information Contact Edward Szymanski
312-275-7795
Manufacturer Reason
for Recall		 May produce erroneously low results from specific well sets.
FDA Determined
Cause 2		 Under Investigation by firm
Action An Urgent Medical Device Recall and an Urgent Field Safety Notice were issued on January 30, 2018 to all Dimension Vista customers who purchased the impacted lot to notify them of the issue, the potential risk to health, and actions to be taken by the customer. Customers were instructed to: "Discontinue use of and discard the Dimension Vista Calcium Flex reagent lot 17171BD. "Please review this letter with your Medical Director. "Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. "Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens Technical Support Representative. For further questions, please call (312) 275-7795.
Quantity in Commerce 6000
Distribution Worldwide Distribution - USA (nationwide) and to the following countries: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Japan, Norway, Portugal, Slovakia, Slovenia, South Korea, Spain, Switzerland
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 = CIC and Original Applicant = DADE BEHRING, INC.
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