Z-1686-2016Class II

Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the...

Name: Z-1686-2016 Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the...
Creator: Diamedix Corporation
Published: 2014-10-20
License: https://open.fda.gov/license/

Diamedix Corp. / initiated 2014-10-20 / Terminated

FDA source

Diamedix Corporation began a recall of Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG... on 2014-10-20. FDA classified it as Class II and gives the reason as "A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1686-2016
Classification: Class II
Status: Terminated
Initiated: 2014-10-20
Posted: 2016-05-16
Terminated: 2016-12-14
Recalling firm: Diamedix Corp.
Product: Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
Product code: LSE Epstein-Barr Virus, Other
Reason for recall: A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
FDA root cause: Unknown/Undetermined by firm
Action: The firm, Diamedix, sent letters dated October 14, October 20 and December 5, 2014 to its customers directly informing them of the correction action. Notification of all domestic customers via Certified Mail. Notification fo the international customers via Federal Express and/or e-mail. With the letter, a replacement bottle of Sample B Diluent was sent and the customer was advised to discard any unused bottles of affected product. New lot number labels were provided to identify kits with the replacement Sample B Diluent. Customers with questions were told they could contact Diamedix Technical Services (1-800-327-4565) if they had any questions or required any additional guidance regarding the correction.
Quantity in commerce: 588 kits
Distribution: Worldwide distribution: US nationwide including states of: AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI and Puerto Rico. and Country of: ITALY.
Product codes and lots: Lot # 30804, Catalog # 720-600 Expiration Date April 30, 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1686-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1685-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-16
Z-1686-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-16
Z-1687-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-16

Product code LSE

K981812Class IEbv-Vca Igg Elisa Test SystemDiamedix Corp. / cleared 1999-03-04

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)