Summary
The FDA issued a Class II for Mycoplasma genitalium Control Panel (Inactivated Pellet) by Microbiologics Inc. Reason: Distributed product did not undergo proper release testing..
Details
Source
Device Recall
External ID
Z-0784-2022
Action Date
2022-03-23
Status
Terminated
Category
device
Product Description
Mycoplasma genitalium Control Panel (Inactivated Pellet)
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)
Quantity Affected: 80 units
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-25
Company
Saint Cloud, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 145 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Microbiologics Inc has 52 FDA actions in our database, including 52 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Microbiologics Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Microbiologics Inc have FDA actions?
Microbiologics Inc has 52 FDA actions in our database, including 52 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0784-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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