Z-0784-2022Class II

Mycoplasma genitalium Control Panel (Inactivated Pellet)

Name: Z-0784-2022 Mycoplasma genitalium Control Panel (Inactivated Pellet)
Creator: Microbiologics Inc
Published: 2022-02-25
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2022-02-25 / Terminated / root cause: manufacturing process

FDA source

Microbiologics Inc began a recall of Mycoplasma genitalium Control Panel (Inactivated Pellet) on 2022-02-25. FDA classified it as Class II and gives the reason as "Distributed product did not undergo proper release testing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0784-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-25
Posted: 2022-03-14
Terminated: 2024-01-16
Recalling firm: Microbiologics, Inc.
Product: Mycoplasma genitalium Control Panel (Inactivated Pellet)
Product code: OHQ Multi-Analyte Controls Unassayed
Reason for recall: Distributed product did not undergo proper release testing.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: All consignees were contacted beginning 02/25/2022 via email. Consignees should read the recall instructions and determine if the product can be used or discarded, depending on user's lab procedures. A response form should be completed and returned to [email protected].
Quantity in commerce: 80 units
Distribution: 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
Product codes and lots: Catalog 8240, Lots: 8240-08, 8240-09, 8240-10, 8240-11, 8240-12, 8240-13, 8240-14, 8240-15, 8240-16 (UDI: 70845357043053)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0784-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0784-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-23	2022-03-14

Product code OHQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)