CLASS II Device recall · Reported 23 Mar 2022 · FDA Enforcement Report

Mycoplasma genitalium Control Panel (Inactivated Pellet) recalled

Microbiologics is recalling Mycoplasma genitalium Control Panel (Inactivated Pellet), distributed in 18 states. The recall was initiated on 25 Feb 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog 8240, Lots: 8240-08, 8240-09, 8240-10, 8240-11, 8240-12, 8240-13, 8240-14, 8240-15, 8240-16 (UDI: 70845357043053)

Quantity recalled80 units

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-0784-2022
FDA event ID: 89694
Recalling firm: Microbiologics, Saint Cloud, MN
Classification: Class II
Status: Terminated
Recall initiated: 25 Feb 2022
FDA classified: 14 Mar 2022
Reported: 23 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

25 Feb 2022	Recall initiated by company
14 Mar 2022	Classified by FDA	+17 days
23 Mar 2022	Published in enforcement report	+9 days

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

Reason for recall

Distributed product did not undergo proper release testing.

Product as listed by the FDA

Mycoplasma genitalium Control Panel (Inactivated Pellet)

Where it was distributed

Distribution in US: AZ, CT, DC, FL, IL, IN, KS, KY, MA, MD, NC, NH, NJ, NY, PA, TX, UT, WA OUS distribution to Belgium, Finland, France, Germany, Ireland, Sweden, United Kingdom, and Vietnam

Arizona Connecticut District of Columbia Florida Illinois Indiana Kansas Kentucky Massachusetts Maryland North Carolina New Hampshire New Jersey New York Pennsylvania Texas Utah Washington

Questions about this recall

Why was it recalled?

Distributed product did not undergo proper release testing.

Which lots are affected?

Catalog 8240, Lots: 8240-08, 8240-09, 8240-10, 8240-11, 8240-12, 8240-13, 8240-14, 8240-15, 8240-16 (UDI: 70845357043053)

Where was it sold?

Distribution in US: AZ, CT, DC, FL, IL, IN, KS, KY, MA, MD, NC, NH, NJ, NY, PA, TX, UT, WA OUS distribution to Belgium, Finland, France, Germany, Ireland, Sweden, United Kingdom, and Vietnam

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 26 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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