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U.S. Department of Health and Human Services

Class 3 Device Recall Siemens RAPIDPoint 400 Measurement Cartridge

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  Class 3 Device Recall Siemens RAPIDPoint 400 Measurement Cartridge see related information
Date Initiated by Firm September 02, 2016
Date Posted September 30, 2016
Recall Status1 Terminated 3 on August 07, 2017
Recall Number Z-2912-2016
Recall Event ID 75108
510(K)Number K002738  
Product Classification Coulometric, chloride - Product Code JFS
Product Siemens RAPIDPoint 400 Measurement Cartridge
Siemens SMN numbers:10329756, 10341161
Code Information Serial Numbers:2610900214 through 2621001325 Expiry Dates: Sept 13, 2016 through Dec. 6, 2016
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Dr
Norwood MA 02062-4637
For Additional Information Contact SAME
781-269-3000
Manufacturer Reason
for Recall		 Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens Healthcare issued An Urgent Field Safety Notice via e-mail to affected Siemens Healthcare Diagnostics Regional offices on September 2, 2016 both in the United States and outside of the United States, for communication with affected customers e: the bias of the chloride values. US accounts sent hard copy via Federal Express and requested to: Complete and return the Field Correction Effectiveness Check form attached to this letter within 7 days. Review this letter with your Medical Director. Questions:Contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in Commerce 689 cartridges
Distribution Nationwide: Foreign: Canada, Bahamas,Germany, Japan, Mexico.Belgium, Italy,Spain, Korea, France, Austria, Korea, France, Poland, Australia, china, AE, Bangladesh, Columbia, Czechkoslovakia, Bosnia
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 = JFS and Original Applicant = BAYER CORP.
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