Z-1294-2019Class II

Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 -

Name: Z-1294-2019 Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 -
Creator: Medica Corporation
Published: 2019-02-06
License: https://open.fda.gov/license/

Medica Corp. / initiated 2019-02-06 / Terminated / root cause: manufacturing process

FDA source

Medica Corporation began a recall of 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... on 2019-02-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1294-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-06
Posted: 2019-05-07
Terminated: 2020-10-02
Recalling firm: Medica Corp.
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.
Product code: CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
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.
Root cause tag: manufacturing process
FDA root cause: 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: [email protected].
Quantity in commerce: 87 kits
Distribution: Worldwide distribution - US Nationwide and countries of IRAQ, FRANCE, INDIA, GEORGIA, GEORGIA, FRANCE GUATEMALA, KENYA, IRAN, ESTONIA.
Product codes and lots: Lot #s 18066, 18133, 18235, 18317

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1294-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1294-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-07

Product code CHI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)