Health Canada — Medical Devices · Canada · 2016-09-15 · Type III
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Reported risk: On Sept. 14, 2016, Immucor Inc. (manufacturer of the device) notified dominion biologicals limited of the intent to initiate a medical device recall on Checkcell. Immucor has received customer complaints of increased hemolysis seen in some vials of this lot. Immucor's internal investigation has confirmed an increase in hemolysis in their remaining product inventory. Immucor has performed additional serological testing on retention samples of Lot 31864 and the reagent continues to meet reactivity specifications. Immucor has indicated that testing results, using this lot are valid, provided the reagent meets the requirements for reactivity described in the quality control section of the package insert. The package insert also cautions the user that: antiglobulin control cells should not be used if the cells darken, spontaneously clump or if there is significant hemolysis.
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