Mycoplasma genitalium Control Panel (Inactivated Pellet)
This recall has been terminated (originally issued February 25, 2022).
- Company
- Microbiologics Inc
- Recall Initiated
- February 25, 2022
- Terminated
- January 16, 2024
- Recall Number
- Z-0784-2022
- Quantity
- 80 units
- Firm Location
- Saint Cloud, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Distributed product did not undergo proper release testing.
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
Lot / Code Info
Catalog 8240, Lots: 8240-08, 8240-09, 8240-10, 8240-11, 8240-12, 8240-13, 8240-14, 8240-15, 8240-16 (UDI: 70845357043053)
Root Cause
Nonconforming Material/Component
Action Taken
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 recall@microbiologics.com.