RapidLab 1200 Systems, Model 1245 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics
FDA device recall Z-1464-06 · posted 2006-08-29 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- Domestic - 124 units, Foreign-364 units (all systems)
- Distribution
- Worldwide
- Date initiated
- 2006-04-04
- Date posted
- 2006-08-29
- Date terminated
- 2012-07-30
- 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 |