Recall Z-1149-2018— Medica Corporation

Class II FDA medical device recall by Medica Corporation, initiated 2017-11-21, terminated 2020-08-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution is used prior to a lipase (LIP) assay if an interferant assay (TRIG)is part of the work list. The major interferant for Lipase is the Triglycerides (TRIG) assay since one of the reagents contains lipase as an active ingredient.. Reason: The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Lipase values when analyzing patient samples. The firm's internal investigation identified the underlying cause to be an ineffective wash solution resulting in an interference carryover from the triglyceride (TRIG) assay if they are on the same worklist..

Recalling firm

Medica Corporation

Classification

Class II

Status

Terminated

Initiated

2017-11-21

Terminated

2020-08-20

Firm location

Bedford, MA, United States

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