FilmArray Gastrointestinal recall
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Why was FilmArray Gastrointestinal recalled?
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Pouch Lot# 2N3R22 / Kit Lot# 2160422; UDI-DI: (00)815381020109
- Product
- FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 900 pouches (30 kits)
- Distribution
- US Nationwide distribution in the states of AR, CA, DC, IL, KS, LA, MN, NC, NY, OK, WI.
- Recall date
- April 26, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)