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.
- Company
- Medica Corporation
- Recall Initiated
- February 6, 2019
- Terminated
- October 2, 2020
- Recall Number
- Z-1294-2019
- Quantity
- 87 kits
- Firm Location
- Bedford, MA
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.
Distribution
Worldwide distribution - US Nationwide and countries of IRAQ, FRANCE, INDIA, GEORGIA, GEORGIA, FRANCE GUATEMALA, KENYA, IRAN, ESTONIA.
Lot / Code Info
Lot #s 18066, 18133, 18235, 18317
Root Cause
Process design
Action Taken
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.