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Terminated

Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series.

FDA Recall Z-1317-06 · Posted 2006-08-02

Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2005-06-17
Date Terminated2012-02-24
Product Quantity1635 devices

Reason for Recall

Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase.

Firm Action

The customers were apprised of this situation with a recall letter issued by the firm on 6/17/2005. In addition, new Operators Manuals were sent to the customers. In the letter, the customers were advised that a Service Engineer would be contacting them shortly in order to arrange for the installation of the software upgrade. The firm''s Service Engineers visited each customer location and installed software upgrades. Version 3.831 software was installed on the 700 Series Analyzers and Version 4.14 was installed on the 800 Series Analyzers. According to the firm, these software corrections were verified as having been completed by 3/10/2006.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002290ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)Radiometer Medical A/S · 2000-09-13K992859ABL700 SERIES ANALYZER WITH AUTOCHECK MODULERadiometer America, Inc. · 2000-01-10K991417ABL 735 ANALYZERRadiometer America, Inc. · 1999-11-24

Official Source

View FDA Recall →

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

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