FDAClass IIMay 15, 2019

Medica Wash1-Wash solution used prior to Lipase assay recall

Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washing the…

Why was Medica Wash1-Wash solution used prior to Lipase assay recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #s 18066, 18133, 18235, 18317

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…
Recalling firm
Medica Corporation
Quantity
87 kits
Distribution
Worldwide distribution - US Nationwide and countries of IRAQ, FRANCE, INDIA, GEORGIA, GEORGIA, FRANCE GUATEMALA, KENYA, IRAN, ESTONIA.
Recall date
May 15, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls