(b)(4).Method: cuvette/single-use disposable.As part of itc's investigation, evaluation testing was performed on retain samples of a similar lot.Process evaluation performed.Review and trend analysis of finished product qc test data was performed.Manufacturing process reviewed.Result: an upward shift in non-heparinized blood response when compared to historical performance was identified.Conclusion: manufacturer notified fda on december 6, 2013 of the voluntary recall of (b)(4) lots of hemochron jr.Citrate aptt cuvettes.Itc's investigation into the product's performance identified that the affected lots of j103c cuvettes may recover higher than expected results in normal individuals.When testing non-heparinized (e.G.Normal blood samples), results may average higher than historic values.Test results performed on patients receiving heparin therapy are not affected.The upward shift in non-heparinized blood response is associated with a recent formulary optimization.Correction of the normal range shift being implemented to assure that test results from non-heparinized sampled in future lot releases will perform similar to historic experiences.
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