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U.S. Department of Health and Human Services

Class 2 Device Recall RapidLab 1245 System

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  Class 2 Device Recall RapidLab 1245 System see related information
Date Initiated by Firm April 04, 2006
Date Posted August 29, 2006
Recall Status1 Terminated 3 on July 30, 2012
Recall Number Z-1464-06
Recall Event ID 35944
510(K)Number K031560  
Product Classification Blood Gases - Product Code CHL
Product RapidLab¿ 1200 Systems, Model 1245 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division
Code Information Part No. 05061537; all units using Version 1.0, 1.01, or 1.02 software connected to LIS, Rapidlink¿, or Rapidcomm™ data management systems.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact Mr. Steven Andberg
508-660-8540
Manufacturer Reason
for Recall		 Invalid CO-oximeter values; Bayer HealthCare determined that under very specific conditions, the RapidLab¿ 1245 or RapidLab¿ 1265 systems may report invalid CO-oximeter values to an LIS, Rapidlink¿, or Rapidcomm™ data management system.
FDA Determined
Cause 2		 Software design
Action On 4/04/06, Bayer HealthCare LLC (Diagnostics Division) sent Support Bulletins to all affected Bayer HealthCare LLC Branches via e-mail in order to inform them of the issue, and to provide them with instructions for the interim work-around until the new software version is installed. Customer Bulletins were prepared and sent to the Branches both in the United States and globally for communication with the affected customers.
Quantity in Commerce Domestic - 124 units, Foreign-364 units (all systems)
Distribution Worldwide
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 = CHL and Original Applicant = BAYER HEALTHCARE, LLC
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