Abbott Diabetes Care last week began recalling faulty blood glucose test strips in the U.S. and Puerto Rico. The affected test strips--some 359 million of them--may give false results, providing low blood glucose readings.
The Alameda, CA-based diabetes management company says the strips apparently require more fill time than expected. The longer fill time may be a function of the age of the strips and potential exposure to higher temperatures for an extended period of time.
The company began the recall following a routine quality review that revealed the longer than normal blood fill times.
Abbott Diabetes Care received an FDA warning last July that has the distinction of citing the company for employing operations staff unqualified to ensure product quality. In the warning, the agency compares the educational background and experience of employees against that specified by Abbott in its description of their jobs. One description specifies a Bachelor of Science degree in a technical discipline as a requirement, but the FDA cites Abbott for filling the slot with an employee holding a business administration degree.
That's a "questionable warning letter observation," says Jim Prutow, director at consultancy PRTM's healthcare practice, in an interview last September. "Personnel might have extensive experience in the field, which might be the reason for overlooking their lack of a degree."
-here's the Abbott recall notice