FDAClass IIApril 6, 2022

Pneumonia recall

Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control…

Why was Pneumonia recalled?

Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.

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 Number 8244, UDI: 70845357043664, Lot Number (Expiration Date) (New Expiration Date): 8244 01 (07/31/2022) (07/26/2021), 8244 02 (08/31/2022) (08/02/2021)

Product
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control…
Recalling firm
Microbiologics Inc
Quantity
13 units
Distribution
US distribution to Alabama, Georgia, Illinois, Montana, Pennsylvania, Tennessee, Texas, and Wisconsin
Recall date
April 6, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls