Recall Z-0784-2022
Microbiologics Inc · initiated February 25, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Mycoplasma genitalium Control Panel (Inactivated Pellet)
Codes / lots: Catalog 8240, Lots: 8240-08, 8240-09, 8240-10, 8240-11, 8240-12, 8240-13, 8240-14, 8240-15, 8240-16 (UDI: 70845357043053)
Reason for recall
Distributed product did not undergo proper release testing.
FDA-determined 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.
Details
- Recall number
- Z-0784-2022
- Initiated
- February 25, 2022
- Terminated
- January 16, 2024
- Product code
- OHQ – Multi-Analyte Controls Unassayed
- Quantity
- 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
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN