Brand 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.
FDA Recall Z-0684-06 · Posted 2006-03-29
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Recalling FirmBayer Healthcare, LLC (Diagnostics Division)
Recall StatusTerminated
Product CodeCHL
Date Initiated2006-01-20
Date Terminated2012-05-02
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.
Firm 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).
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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