SIMPLEXA COVID-19 Positive Control Pack recall
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Why was SIMPLEXA COVID-19 Positive Control Pack recalled?
Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
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?
Lot #/Expiration Date: 12175N/11.30.2021, 12722N/01.31.2022, X12122N/01.31.2022, X12724N/08.31.2022
- Product
- SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
- Recalling firm
- DiaSorin Molecular LLC
- Quantity
- 1690 kits
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OH, OK, PA, SD, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Italy.
- Recall date
- October 27, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)