CLASS III Device recall · Reported 8 Aug 2018 · FDA Enforcement Report
Is-Ebv-ea-d IgG Enzyme Immunoassay Test Kit recalled by Diamedix
Diamedix is recalling Diamedix Is-Ebv-ea-d IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use, distributed in 20 states. The recall was initiated on 5 Jan 2018 and the FDA has classified it as Class III.
Check your package
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-2574-2018
- FDA event ID
- 80441
- Recalling firm
- Diamedix, Miami Lakes, FL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Jan 2018
- FDA classified
- 28 Jul 2018
- Reported
- 8 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 5 Jan 2018 | Recall initiated by company | |
| 28 Jul 2018 | Classified by FDA | +204 days |
| 8 Aug 2018 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Contains a gel-like contaminant that may affect product performance.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
Where it was distributed
AZ, CA, FL, IL, IN, KY, MA, MI, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN, TX, and WI
ArizonaCaliforniaFloridaIllinoisIndianaKentuckyMassachusettsMichiganMinnesotaMissouriNew HampshireNew JerseyNew YorkOhioOklahomaPennsylvaniaRhode IslandTennesseeTexasWisconsin
Questions about this recall
Is Is-Ebv-ea-d IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use recalled?
Yes. Diamedix recalled Is-Ebv-ea-d IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use on 5 Jan 2018. The recall is Class III and its status is Terminated. Recall number Z-2574-2018.
Why was it recalled?
Contains a gel-like contaminant that may affect product performance.
Which lots are affected?
Lot T0006 Exp. 05/31/2018
Where was it sold?
AZ, CA, FL, IL, IN, KY, MA, MI, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN, TX, and WI
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use recalled | Diamedix | Potency & Assay | 20 states |
| Device | CLASS II | Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is recalled | Diamedix | Other | Nationwide |
| Device | CLASS II | Is-CMV IgG Test Kit recalled by Diamedix | Diamedix | Other | 20 states |
| Device | CLASS II | Is-Ebv-ea-d IgG Test Kit Diamedix Is-Mumps IgG Test Kit is recalled | Diamedix | Other | Nationwide |
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