FDAClass IIApril 27, 2022

Inactivated macrolide-resistant Mycoplasma genitalium recall

Inactivated macrolide-resistant Mycoplasma genitalium

Why was Inactivated macrolide-resistant Mycoplasma genitalium recalled?

The QC process was not adequate for the specification range.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog # HE0070N; Lot HE0070-01-1 UDI: 10845357044003

Product
Inactivated macrolide-resistant Mycoplasma genitalium
Recalling firm
Microbiologics Inc
Quantity
2 ea
Distribution
US Nationwide distribution in the states of NV and VT.
Recall date
April 27, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls