Brand Name: RapidLab 1200 System, Model 1265, Part Number 05063769; All RapidLab 1200 Systems with Software Versions 1.0
FDA device recall Z-0685-06 · posted 2006-03-29 · Terminated
Recall details
- Recalling firm
- Bayer Healthcare, LLC (Diagnostics Division)
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- CHL
- 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, Switze
- Date initiated
- 2006-01-20
- Date posted
- 2006-03-29
- Date terminated
- 2012-05-02
- Location
- Tarrytown, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BAYER RAPIDLAB 1200 SYSTEM (K031560) | Bayer Healthcare, LLC | 2003-12-17 |