CLASS II Device recall · Reported 25 May 2016 · FDA Enforcement Report

Is-CMV IgG Test Kit recalled by Diamedix

Diamedix is recalling Diamedix Is-CMV IgG Test Kit, distributed in 20 states. The recall was initiated on 26 Mar 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog # 720-320 Lot # 10105 Expiration Date January 31, 2016

Quantity recalled150 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1689-2016
FDA event ID: 73194
Recalling firm: Diamedix, Miami Lakes, FL
Classification: Class II
Status: Terminated
Recall initiated: 26 Mar 2015
FDA classified: 17 May 2016
Reported: 25 May 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

26 Mar 2015	Recall initiated by company
17 May 2016	Classified by FDA	+418 days
25 May 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product contained an incorrect substrate.

Product as listed by the FDA

Diamedix Is-CMV IgG Test Kit

Where it was distributed

AZ, CA, FL, GA, KY, MA, MI, MN, MO, NC, NE, NY, OH, OK, OR, TN, TX, VA, WI and Puerto Rico.

Arizona California Florida Georgia Kentucky Massachusetts Michigan Minnesota Missouri North Carolina Nebraska New York Ohio Oklahoma Oregon Puerto Rico Tennessee Texas Virginia Wisconsin

Questions about this recall

Is Is-CMV IgG Test Kit recalled?

Yes. Diamedix recalled Is-CMV IgG Test Kit on 26 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-1689-2016.

Why was it recalled?

Product contained an incorrect substrate.

Which lots are affected?

Catalog # 720-320 Lot # 10105 Expiration Date January 31, 2016

Where was it sold?

AZ, CA, FL, GA, KY, MA, MI, MN, MO, NC, NE, NY, OH, OK, OR, TN, TX, VA, WI and Puerto Rico.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Diamedix

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Reported	Class	Recall	Company	Reason	Where
8 Aug 2018Device	CLASS III	Is-Ebv-ea-d IgG Enzyme Immunoassay Test Kit recalled by Diamedix	Diamedix	Potency & Assay	20 states
8 Aug 2018Device	CLASS III	Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use recalled	Diamedix	Potency & Assay	20 states
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