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U.S. Department of Health and Human Services

Class 2 Device Recall RapidLab1200 System

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 Class 2 Device Recall RapidLab1200 Systemsee related information
Date Initiated by FirmJanuary 20, 2006
Date PostedMarch 29, 2006
Recall Status1 Terminated 3 on May 02, 2012
Recall NumberZ-0684-06
Recall Event ID 34505
510(K)NumberK031560 
Product Classification Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph - Product Code CHL
ProductBrand Name: RapidLab 1200 System, Model 1260, Part Number 05062460; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test system.
Code Information All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02.
FEI Number 2432235
Recalling Firm/
Manufacturer		 Bayer Healthcare, LLC (Diagnostics Division)
511 Benedict Avenue
Tarrytown NY 10591
For Additional Information ContactSteven Andberg
508-660-8540
Manufacturer Reason
for Recall		When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1.0, 1.01, or 1.02. The correlation feature applies user-defined slope and offset parameters each time stored test results are recalled to the display.
FDA Determined
Cause 2		Other
ActionSupport Bulletins and Customer Bulletins were e-mailed to all Bayer HealthCare LLC Branches on 1/20/06 for distribution to the end user facilities (medical facilities).
DistributionUSA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hong Kong, Italy, Japan, Korea, Malaysia, The Netherlands, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CHL
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