ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists, nurses, physicians and therapists. They are intended for use in a laboratory environment, near patient or point-of-care setting.
FDA Recall Z-2304-2012 · Posted 2012-08-30
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Recalling FirmSendx Medical Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2012-06-06
Date Terminated2012-09-04
Product QuantityABL80 FLEX is 1680, ABL80 CO-OX is 1759
Reason for Recall
The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition.
Firm Action
Radiometer sent a Field Safety Notice letter dated June 06, 2012 via email to all affected customers. The letter identified the affected product, problem and actions to be taken. Also included is a Note to Users to be placed at the front of customers existing Operator's Manual. Customers were instructed to provide confirmation to Radiometer that all customers have received the letter and the Note to Users. For questions contact your Radiometer representative.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - US Nationwide including the state of OH.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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