Z-1689-2016Class II

Diamedix Is-CMV IgG Test Kit

Name: Z-1689-2016 Diamedix Is-CMV IgG Test Kit
Creator: Diamedix Corporation
Published: 2015-03-26
License: https://open.fda.gov/license/

Diamedix Corp. / initiated 2015-03-26 / Terminated

FDA source

Diamedix Corporation began a recall of Diamedix Is-CMV IgG Test Kit on 2015-03-26. FDA classified it as Class II and gives the reason as "Product contained an incorrect substrate". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1689-2016
Classification: Class II
Status: Terminated
Initiated: 2015-03-26
Posted: 2016-05-17
Terminated: 2018-11-14
Recalling firm: Diamedix Corp.
Product: Diamedix Is-CMV IgG Test Kit
Product code: LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Reason for recall: Product contained an incorrect substrate.
FDA root cause: Other
Action: On March 26, 2015 Erba Diagnostics sent a communication to their clients informing them of the recall and sending t hem a replacement sustrate HRP to replaced the wrong one sent on the kit.
Quantity in commerce: 150 kits
Distribution: AZ, CA, FL, GA, KY, MA, MI, MN, MO, NC, NE, NY, OH, OK, OR, TN, TX, VA, WI and Puerto Rico.
Product codes and lots: Catalog # 720-320 Lot # 10105 Expiration Date January 31, 2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1689-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1689-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-17

Product code LFZ

K981163Class IIDiamedix Is-Cmv Igg Test SystemDiamedix Corp. / cleared 1998-09-21

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)