Brand Name: RapidLab 1200 System, Model 1260, Part Number… recallZ-0684-06 · Bayer Healthcare, LLC (Diagnostics Division) · initiated Jan 20, 2006

Terminated All recalls posted in March 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 Bayer Healthcare, LLC (Diagnostics Division) 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

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.

FDA root cause category: Other

What the company is doing

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).

Recall details

Recall number: Z-0684-06
Recall class: Not yet classified by the FDA
Status: Terminated
Initiated by the company: Jan 20, 2006
Posted by the FDA: Mar 29, 2006
Recalling firm: Bayer Healthcare, LLC (Diagnostics Division)
Product code: CHL
FDA submissions: K031560
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.

Product description

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.

Code information (models, lots, serial numbers)

All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02.

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 10321852
Siemens Healthcare Diagnostics Inc. · ELECTRODE, ION SPECIFIC, CALCIUM
12 reports
RAPIDLab® 1200 Series 1240 10321840
Siemens Healthcare Diagnostics Inc. · ELECTRODE, ION-SPECIFIC, CHLORIDE
1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 34505).

Z-0682-06 · Terminated
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 a…
Z-0683-06 · Terminated
Brand Name: RapidLab 1200 System, Model 1245, Part Number 05061537; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte a…
Z-0685-06 · Terminated
Brand Name: RapidLab 1200 System, Model 1265, Part Number 05063769; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte …

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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