Z-1149-2018Class II

Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry...

Name: Z-1149-2018 Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry...
Creator: Medica Corporation
Published: 2017-11-21
License: https://open.fda.gov/license/

Medica Corp. / initiated 2017-11-21 / Terminated

FDA source

Medica Corporation began a recall of Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA... on 2017-11-21. FDA classified it as Class II and gives the reason as "The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Lipase values when analyzing patient samples. The firm's internal investigation identified the underlying cause to be an...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1149-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-21
Posted: 2018-03-21
Terminated: 2020-08-20
Recalling firm: Medica Corp.
Product: Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution is used prior to a lipase (LIP) assay if an interferant assay (TRIG)is part of the work list. The major interferant for Lipase is the Triglycerides (TRIG) assay since one of the reagents contains lipase as an active ingredient.
Product code: CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Reason for recall: The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Lipase values when analyzing patient samples. The firm's internal investigation identified the underlying cause to be an ineffective wash solution resulting in an interference carryover from the triglyceride (TRIG) assay if they are on the same worklist.
FDA root cause: Under Investigation by firm
Action: Firm emailed all consignees and instructed them to remove/discard affected wedges (bottles) and contact Medica for immediate replacement 1 Immediately discontinue use of the Wash1 wedges (REF 10680) (Lot# listed above) and discard any remaining kits/wedges. 2. Please 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. 3.Submit claims for replacement of affected product to your authorized Medica EasyRA dealer. For further questions, please call (781) 541-7560.
Quantity in commerce: 392
Distribution: Worldwide and US Distribution.
Product codes and lots: Lots 16279, 17045 and 17215

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1149-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1149-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-21

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)