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Terminated

Bayer Rapidpoint 405 Blood Gas Analyzer

FDA Recall Z-0066-04 · Posted 2003-10-24

Recalling FirmBayer Corp.
Recall StatusTerminated
Product CodeCHL
Date Initiated2003-09-26
Date Terminated2004-02-04
Product Quantity494 units

Reason for Recall

Potential for bias shift in pO2 values due to air bubble in sample path

Firm Action

Bayer notified each customer by telephone and followed with a FedEx letter dated 9/26/03 providing upgraded software version 3.1 to install .

Root Cause

Other

Distribution Pattern

Nationwide Foreign: Australia, Austria, Belgium. Canada, France, Germany, Italy, Japan, Korea, Mexico, Netherlands, Russia, S Ireland, Spain, Switzerland

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020616BAYER RAPIDPOINT 405 SYSTEMBayer Diagnostics Corp. · 2002-07-17

Official Source

View FDA Recall →

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

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