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Class 2 Device Recall RapidLab1200 System |
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Date Initiated by Firm |
January 20, 2006 |
Date Posted |
March 29, 2006 |
Recall Status1 |
Terminated 3 on May 02, 2012 |
Recall Number |
Z-0682-06 |
Recall Event ID |
34505 |
510(K)Number |
K031560
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Product Classification |
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph - Product Code CHL
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Product |
Brand Name: RapidLab 1200 System, Model 1240, Part Number 05060298; 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. |
Recalling Firm/ Manufacturer |
Bayer Healthcare, LLC (Diagnostics Division) 511 Benedict Avenue Tarrytown NY 10591
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For Additional Information Contact |
Steven Andberg 508-660-8540
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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.
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FDA Determined Cause 2 |
Other |
Action |
Support 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). |
Distribution |
USA, 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 Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = CHL and Original Applicant = BAYER HEALTHCARE, LLC
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