As the suspect device was not returned, no evaluation could be completed.However, the alleged strip lot is from the list of affected lots included in res 80018.Due to the alleged lot being associated with the reagent cracking failure mode, it is possible that reagent cracking could have caused or contributed to the customer¿s allegation even though it was not reproduced.The allegation was not able to be reproduced but the complaint is being verified based on a known issue with the alleged strip lot.
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