FDAClass IIMarch 23, 2022

Mycoplasma genitalium Control Panel recall

Mycoplasma genitalium Control Panel (Inactivated Pellet)

Why was Mycoplasma genitalium Control Panel recalled?

Distributed product did not undergo proper release testing.

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 8240, Lots: 8240-08, 8240-09, 8240-10, 8240-11, 8240-12, 8240-13, 8240-14, 8240-15, 8240-16 (UDI: 70845357043053)

Product
Mycoplasma genitalium Control Panel (Inactivated Pellet)
Recalling firm
Microbiologics Inc
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
Recall date
March 23, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls