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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens RAPIDPoint 500 Blood Gas Analyzer

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  Class 2 Device Recall Siemens RAPIDPoint 500 Blood Gas Analyzer see related information
Date Initiated by Firm December 30, 2014
Date Posted March 06, 2015
Recall Status1 Terminated 3 on August 02, 2017
Recall Number Z-1253-2015
Recall Event ID 70203
510(K)Number K113216  
Product Classification Bilirubin (total and unbound) in the neonate test system - Product Code MQM
Product RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 10696855, 10696857, 10697306.

The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili.
Code Information All serial numbers.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Drive
Norwood MA 02062
For Additional Information Contact Steven H. Andberg
781-269-3655
Manufacturer Reason
for Recall		 Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl.
FDA Determined
Cause 2		 Software design
Action An Urgent Field Safety Notice was sent by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on December 30, 2014 both in the United States and elsewhere for communication with affected customers. In addition, all affected domestic customers were sent a hard copy of the Urgent Field Safety Notice via Federal Express on December 30, 2014. All affected customers outside the US will be provided a copy of an Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each countries local regulations and procedures. This notice informs consignees of the issue. Consignees are also asked to complete a field effectiveness check form and return it Siemens via fax (312) 275-7795.
Quantity in Commerce 4376 devices
Distribution Worldwide Distribution - US nationwide including Puerto Rico, Canada, Mexico, Albania, Algeria, Argentina, Austria, Bahrain, Belgium, Bosnia Herzegovina, Botswana, Brazil, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Iraq, Ireland, Israel, Italy, Ivory Coast, Kazakhstan, Kuwait, Latvia, Lebanon, Lesotho, Lithuania, Luxembourg, Macedonia, Netherlands, New Caledonia, Norway, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, U.A.E., United Kingdom, Vatican City, Venezuela, White Russia/Belarus.
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 = MQM and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
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