Simplexa Flu A/B & RSV Direct Gen II recall: Contamination
Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.
Why was Simplexa Flu A/B & RSV Direct Gen II recalled?
Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
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?
UDI-DI: 20816101026962. Product REF/Lot/Reaction Mix REF/Lot: MOL2655/13648N/MOL2656/13649N, MOL2655/13882N/MOL2656/15164N, MOL2655/15279N/MOL2656/15280N
- Product
- Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.
- Recalling firm
- DiaSorin Molecular LLC
- Quantity
- 4142
- Distribution
- US Nationwide distribution including in the states of NJ, ME, ND, IL, MI, FL, GA, AZ, MA, CA, MO, SD, MN, PA, OH, VT, NE, WI, CO, DC, VA, TX, NH, IN, IA, MD, NC, AL, NY, KY, WV, RI, KS, NM, OK, WA, SC, CT, TN, NV, LA.
- Recall date
- March 15, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)