Conclusion section revised to reflect updated information: maintenance deficiency - insufficient preventative maintenance and less than optimal equipment settings resulting in diminished performance.Manufacturing deficiency - insufficiently effective quality checks during the test strip manufacturing process.Design deficiency - packaging configuration allowed for excessive agitation of test strips and insufficient protection against temperature extremes during transportation.Based on the available evidence, beckman coulter (bec) has determined the cause of the reported event that triggered this recall action 2050012-0120/2016-001c, reported initially to the (b)(4) district office on 01/20/2016, in accordance with 21 cfr 806).As of august 19, 2016 fda recall number z-1067-2016 (2050012-0120/2016-001c) has been closed.
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