Retain samples of precision test strip lots manufactured with hot-melt glue batches exhibited lower than expected readings on continuous storage after nine months at 30 degrees celsius during routine stability performance testing.This stability issue could lead to the generation of incorrectly depressed blood glucose results and these erroneous results may be in the c, d, or e zones of parkes error grid, and as such, have the potential to be clinically significant.Customers were notified through remedial action adc fa1197-2010.All pertinent information available to abbott diabetes care has been submitted.Note: the "date of event" is unknown.The device manufacturer date for the reported product is unknown.
|