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U.S. Department of Health and Human Services

Class 2 Device Recall Chemistry Wash1 REF 10680

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 Class 2 Device Recall Chemistry Wash1 REF 10680see related information
Date Initiated by FirmNovember 21, 2017
Create DateMarch 21, 2018
Recall Status1 Terminated 3 on August 20, 2020
Recall NumberZ-1149-2018
Recall Event ID 79264
Product Classification Lipase-esterase, enzymatic, photometric, lipase - Product Code CHI
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.
Code Information Lots 16279, 17045 and 17215
FEI Number 1220972
Recalling Firm/
Manufacturer		 Medica Corporation
5 Oak Park Dr
Bedford MA 01730-1430
For Additional Information ContactRandy Rollins
781-541-7560
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Under Investigation by firm
ActionFirm emailed all consignees and instructed them to remove/discard affected wedges (bottles) and contact Medica for immediate replacement 1 Immediately discontinue use of the Wash1 wedges (REF 10680) (Lot# listed above) and discard any remaining kits/wedges. 2. Please discuss possible concerns about lipase results achieved using these lots of Wash wedges with your laboratory manager and/or clinician in order to decide on appropriate measures. Report any concerns to Medica for evaluation and review. 3.Submit claims for replacement of affected product to your authorized Medica EasyRA dealer. For further questions, please call (781) 541-7560.
Quantity in Commerce392
DistributionWorldwide and US Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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