In Vitro Diagnostic recall
In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
Why was In Vitro Diagnostic recalled?
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
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?
Part Number: RFIT-ASY-0116 UDI: 00815381020109 Pouch Lot Number: 1674322
- Product
- In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 2 kits
- Distribution
- U.S. Nationwide distribution in the states of FL and GA.
- Recall date
- March 22, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)