CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report

Vaginal Verification Panel recalled by Microbiologics

Microbiologics is recalling Vaginal Verification Panel, distributed in 8 states. The recall was initiated on 3 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 8208-11

Quantity recalled9

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-1096-2020
FDA event ID: 84634
Recalling firm: Microbiologics, Saint Cloud, MN
Classification: Class II
Status: Terminated
Recall initiated: 3 Jan 2020
FDA classified: 5 Feb 2020
Reported: 12 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 Jan 2020	Recall initiated by company
5 Feb 2020	Classified by FDA	+33 days
12 Feb 2020	Published in enforcement report	+7 days

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

Reason for recall

Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2 (subcomponent 6063). Candida krusei is an organism intended to be contained in Pool 6 of the kit. This should have no impact on patient test results as long as Gardnerella vaginalis was properly detected when using Pool 2 and/or users are strictly using this product for instrument verification/validation.

Product as listed by the FDA

Vaginal Verification Panel Ref 8208 Lot 8208-11

Where it was distributed

Distributed in the US to 7 states: CA, KS, ME, NC, NY, OR, and UT. No Canada, Mexico or VA.

California Kansas Maine North Carolina New York Oregon Utah Virginia

Questions about this recall

Is Vaginal Verification Panel recalled?

Yes. Microbiologics recalled Vaginal Verification Panel on 3 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-1096-2020.

Why was it recalled?

Which lots are affected?

Lot 8208-11

Where was it sold?

Distributed in the US to 7 states: CA, KS, ME, NC, NY, OR, and UT. No Canada, Mexico or VA.

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.

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