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Terminated

RapidLab 1200 Systems, Model 1265 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division

FDA Recall Z-1465-06 · Posted 2006-08-29

Recalling FirmSiemens Healthcare Diagnostics
Recall StatusTerminated
Product CodeCHL
Date Initiated2006-04-04
Date Terminated2012-07-30
Product QuantityDomestic - 124 units, Foreign-364 units (all systems)

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.

Firm Action

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

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031560BAYER RAPIDLAB 1200 SYSTEMBayer Healthcare, LLC · 2003-12-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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