Z-0784-2022 Class II Terminated
FDA device recall Z-0784-2022 was initiated by Microbiologics Inc on Feb 25, 2022 and is designated Class II. Reason for recall: Distributed product did not undergo proper release testing. The recall status is terminated (terminated Jan 16, 2024). Affected quantity: 80 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 23, 2022
- Initiation Date
- Feb 25, 2022
- Termination Date
- Jan 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80 units
Product Description
Mycoplasma genitalium Control Panel (Inactivated Pellet)
Reason for Recall
Distributed product did not undergo proper release testing.
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
Code Information
Catalog 8240, Lots: 8240-08, 8240-09, 8240-10, 8240-11, 8240-12, 8240-13, 8240-14, 8240-15, 8240-16 (UDI: 70845357043053)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0784-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026