RapidLab 1200 Systems, Model 1265 - Blood gases… recallZ-1465-06 · Siemens Healthcare Diagnostics · initiated Apr 4, 2006
Terminated All recalls posted in August 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1465-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 4, 2006
- Posted by the FDA
- Aug 29, 2006
- Recalling firm
- Siemens Healthcare Diagnostics
- Quantity
- Domestic - 124 units, Foreign-364 units (all systems)
- Product code
- CHL
- FDA submissions
- K031560
- Distribution
- Worldwide
Product description
RapidLab 1200 Systems, Model 1265 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division
Code information (models, lots, serial numbers)
Part No. 05063769; all units using Version 1.0, 1.01, or 1.02 software connected to LIS, Rapidlink¿, or Rapidcomm data management systems.
Other devices under the same FDA submission
2 devices cleared under K031560 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- RAPIDLab® 1200 Series 1265 10321852Siemens Healthcare Diagnostics Inc. · ELECTRODE, ION SPECIFIC, CALCIUM12 reports
- RAPIDLab® 1200 Series 1240 10321840Siemens Healthcare Diagnostics Inc. · ELECTRODE, ION-SPECIFIC, CHLORIDE1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 35944).
- Z-1464-06 · TerminatedRapidLab 1200 Systems, Model 1245 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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