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Terminated

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.

FDA Recall Z-1294-2019 · Posted None

Recalling FirmMedica Corporation
Recall StatusTerminated
Product CodeCHI
Date Initiated2019-02-06
Date Terminated2020-10-02
Product Quantity87 kits

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.

Firm 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: [email protected].

Root Cause

Process design

Distribution Pattern

Worldwide distribution - US Nationwide and countries of IRAQ, FRANCE, INDIA, GEORGIA, GEORGIA, FRANCE GUATEMALA, KENYA, IRAN, ESTONIA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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