ABL90 FLEX Blood Analyzer Part Number: 393-090. Intended for use by trained technologists, nurses, physicians and therapists and for use in a laboratory environment, near patient or point-of-care setting. Also, Intended for in vitro testing of samples of heparinized whole blood.
FDA Recall Z-1011-2011 · Posted 2011-02-02
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Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeCEM
Date Initiated2010-11-01
Date Terminated2012-05-09
Product Quantity432 units
Reason for Recall
Due to a software error, a patient mix up can occur on the ABL90. If a sample is pre-registered and the sample "fails" the next result will inherit the patient data from the previous result.
Firm Action
On 11/16/10 the firm sent Medical Device Field Correction letters to their customers. The letter states that all systems will be upgraded and until each system is upgraded, they instructed their customer to "always query for patient ID prior to introducing the sample." They also instruct each customer to complete the "Fax Return Form" acknowledging receipt of the letter. If customers have questions regarding the letter or the upgrade, they should contact Technical Support at 1-800-736-0600 Opt 4.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution -- USA, including states of MI, NJ, & PA and countries Australia, Austria, Belgium, Denmark, Finland, France, Germany, Indonesia, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland, United Arab Emirates & United Kingdom.
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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