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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Healthcare Diagnostics

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  Class 2 Device Recall Siemens Healthcare Diagnostics see related information
Date Initiated by Firm May 23, 2014
Date Posted July 18, 2014
Recall Status1 Terminated 3 on June 10, 2015
Recall Number Z-2079-2014
Recall Event ID 68437
510(K)Number K113216  
Product Classification Acid, lactic, enzymatic method - Product Code KHP
Product RAPIDPoint 500 Measurement Clinical Chemistry System
RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests)
Part number: 10491449;
RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests)
Part Number: 10491448
RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests)
Part Number: 10491447
RAPIDPoint 500 Measurement Cartridge Lactate (100 Tests)
Part Number:10844813
Code Information Serial Numbers: 2334500011 through 2412705915
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Drive
Norwood MA 02062
For Additional Information Contact
781-269-3000
Manufacturer Reason
for Recall		 RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-)
FDA Determined
Cause 2		 Process design
Action Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on May 27, 2014 both in the United States and elsewhere for communication with affected customers. This notice informs customers of the issue with the RAPIDPoint 500 Measurement cartridges. Questions contact: Siemens Customer Care Center or your local Siemens technical support representative at 877-229-3711. What steps can be taken to mitigate the issue: " Install a new RAPIDPoint 500 Measurement Cartridge. or " Install a 405 Measurement Cartridge - The RAPIDPoint 405 cartridge is available in four sizes: Since the Lactate parameter is not available on the RAPIDPoint 405 cartridge, however, you will need to arrange to get your lactate results from other instruments in your central laboratory. or " Use an alternative system to obtain your electrolyte values.
Quantity in Commerce 20,507 cartridges
Distribution Nationwide Foreign: U.A.E. Albania Austria Australia Bosnia Herzeg. Belgium Bulgaria Bahrain Brazil Canada Switzerland P.R. China Colombia Czech Republic Germany Denmark Algeria Estonia Egypt Spain Finland France United Kingdom Georgia Greece Hong Kong Croatia Hungary Indonesia Ireland Israel India Italy Japan Republic Korea Kuwait Lithuania Luxembourg Latvia Malaysia Mexico Netherlands Norway New Zealand Peru Poland Portugal Qatar Romania Serbia Russian Fed. Saudi Arabia Sweden Singapore Slovenia Turkey Taiwan
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 = KHP and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
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