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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 August 03, 2016
Date Posted October 04, 2016
Recall Status1 Terminated 3 on May 11, 2017
Recall Number Z-0039-2017
Recall Event ID 74987
510(K)Number K061792  
Product Classification Cresolphthalein complexone, calcium - Product Code CIC
Product Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge
Device Listing No.: D011443
Batch Number: 16060BB
Code Information Device Listing No: D011443 Batch Number 16060BB
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact
800-441-9250
Manufacturer Reason
for Recall		 Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets.
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens mailed on August 09, 2016, an Urgent Medical Device Recall letter to all customers who purchased the CA lot 16060BB. The notification letter requested that customers discontinue use and discard the affected kit.
Quantity in Commerce 5,991 cartridges
Distribution Distributed Nationwide and the countries of : Austria, Bahamas, Belgium, Canada, Czech Republic, Denmark, Germany, Italy, Japan, Netherlands, Portugal, Saudi Arabia, South Korea, Slovenia, and Spain.
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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