CLASS II Device recall · Reported 9 Sep 2015 · FDA Enforcement Report

MicroVue Bb Plus EIA is packaged as a kit which contains recalled

Diagnostic Hybrids is recalling MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to, distributed in 11 states. The recall was initiated on 16 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number A027; Lot Number 018186; (self-affixed, EDMA Code: 12 01 02 04 00; Complement Component Bb)

Quantity recalled171

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-0417-2015
FDA event ID: 69545
Recalling firm: Diagnostic Hybrids, Athens, OH
Classification: Class II
Status: Terminated
Recall initiated: 16 Oct 2014
FDA classified: 3 Sep 2015
Reported: 9 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Test Kits & Diagnostics

Timeline

16 Oct 2014	Recall initiated by company
3 Sep 2015	Classified by FDA	+322 days
9 Sep 2015	Published in enforcement report	+6 days

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

Reason for recall

Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.

Where it was distributed

Worldwide Distribution - USA, including AL, CO, CT, FL, KY, MN, NC, NV, OH, PA, and WA; and, the countries of Canada, China, India, and Switzerland.

Alabama Colorado Connecticut Florida Kentucky Minnesota North Carolina Nevada Ohio Pennsylvania Washington

Questions about this recall

Is MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to recalled?

Yes. Diagnostic Hybrids recalled MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to on 16 Oct 2014. The recall is Class II and its status is Terminated. Recall number Z-0417-2015.

Why was it recalled?

Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.

Which lots are affected?

Model Number A027; Lot Number 018186; (self-affixed, EDMA Code: 12 01 02 04 00; Complement Component Bb)

Where was it sold?

Worldwide Distribution - USA, including AL, CO, CT, FL, KY, MN, NC, NV, OH, PA, and WA; and, the countries of Canada, China, India, and Switzerland.

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 Diagnostic Hybrids

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Reported	Class	Recall	Company	Reason	Where
16 May 2018Device	CLASS II	MicroVue BAP EIA recalled by Diagnostic Hybrids	Diagnostic Hybrids	Packaging Defects	12 states
2 May 2018Device	CLASS III	MicroVue CIC-C1q EIA recalled by Diagnostic Hybrids	Diagnostic Hybrids	Other	Nationwide
2 May 2018Device	CLASS III	MicroVue SC5b-9 Plus EIA (RUO) recalled by Diagnostic Hybrids	Diagnostic Hybrids	Potency & Assay	Nationwide
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2 May 2018Device	CLASS II	MicroVue CIC-C1q EIA recalled by Diagnostic Hybrids	Diagnostic Hybrids	Potency & Assay	4 states

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