Health Canada — Medical Devices · Canada · 2018-01-08 · Type II
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Reported risk: Iris Diagnostics has become aware of a strip manufacturing error where an incorrect pad was inadvertently placed in the location of the leukocytes pad. All other analytes are correct. This defect exists on a subset of vials belonging to Lot # 7212154 A, with the impacted vial numbers ranging from 01520 through 02401.
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