Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series, manufactured from 8/1998 through 11/2004.
FDA Recall Z-1386-06 · Posted 2006-08-10
Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeJFP
Date Initiated2005-09-29
Date Terminated2012-04-17
Product Quantity1615 devices
Reason for Recall
Under certain circumstances, the ABL 700 & 800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently provide incorrect (too low) result values for Calcium (Ca) and Sodium (Na).
Firm Action
The consignees were notified of this recall by a letter, dated 9/29/2005. The letter informs the customers of this potential problem and the availability of new updated software which will correct the problem. The letter goes on to inform the customer that a Radiometer Service Engineer wil be contacting them shortly in order to arrange for a convenient time to install the software update. Along with the letter, the customer is provided a copy of an additional page and a CD concerning the function and operation of the new software, which is to be added to the customer''s Operator''s Manual.
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. · 1999-11-24K980130ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEMRadiometer America, Inc. · 1998-02-09
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.