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Terminated

Mycoplasma genitalium Control Panel (Inactivated Pellet)

FDA Recall Z-0784-2022 · Posted None

Recalling FirmMicrobiologics Inc
Recall StatusTerminated
Product CodeOHQ
Date Initiated2022-02-25
Date Terminated2024-01-16
Product Quantity80 units

Reason for Recall

Distributed product did not undergo proper release testing.

Firm 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].

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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