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U.S. Department of Health and Human Services

Class 2 Device Recall Medica

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  Class 2 Device Recall Medica see related information
Date Initiated by Firm February 06, 2019
Create Date May 07, 2019
Recall Status1 Terminated 3 on October 02, 2020
Recall Number Z-1294-2019
Recall Event ID 82217
Product Classification Lipase-esterase, enzymatic, photometric, lipase - Product Code CHI
Product Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer
REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wash solution in the wedge is used to prevent interference between certain tests.
Code Information Lot #s 18066, 18133, 18235, 18317
Recalling Firm/
Manufacturer		 Medica Corporation
5 Oak Park Dr
Bedford MA 01730-1430
For Additional Information Contact Randy Rollins
800-777-5983
Manufacturer Reason
for Recall		 Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Lipase (LIP) assay on the EasyRA clinical chemistry analyzer.
FDA Determined
Cause 2		 Process design
Action Medica issued letters dated 2/8/19 via email Bulletin B1901 & B1902 to distributors and end-users on record. Letter describes problem, action to be taken: Immediately discontinue use of the Wash1 wedges (REF 10680) and discard any remaining kits/wedges. Complete the response form. 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. Questions contact Medica Technical Support at (877) 777-5895 or via email at: EasyRAtech@medicacorp.com.
Quantity in Commerce 87 kits
Distribution Worldwide distribution - US Nationwide and countries of IRAQ, FRANCE, INDIA, GEORGIA, GEORGIA, FRANCE GUATEMALA, KENYA, IRAN, ESTONIA.
Total Product Life Cycle TPLC 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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