Summary
The FDA issued a Class II for Inactivated macrolide-resistant Mycoplasma genitalium by Microbiologics Inc. Reason: The QC process was not adequate for the specification range..
Details
Source
Device Recall
External ID
Z-0955-2022
Action Date
2022-04-27
Status
Terminated
Category
device
Product Description
Inactivated macrolide-resistant Mycoplasma genitalium
Lot/Code Info: Catalog # HE0070N; Lot HE0070-01-1 UDI: 10845357044003
Quantity Affected: 2 ea
Reason for Recall
The QC process was not adequate for the specification range.
Distribution
US Nationwide distribution in the states of NV and VT.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-22
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 150 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-0955-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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