Simplexa Direct Amplification Disc Kit recall: Contamination
Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
Why was Simplexa Direct Amplification Disc Kit recalled?
A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.
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?
Kit Product Code MOL1455 (UDI 01-30816101025092) contains 3 discs with Disc Product Code MOL1452. Below lists the MOL1455 Kit Lot numbers (and MOL1452 Disc Lot Numbers): 12410N (12152N), 12411N (12147N), 12413N (12149N), 12477N (12150N), 12602N (11548NA), 12603N (12144N), 12721N (12148N), 12889N (12151N), 13369N (12817N), 13370N (13151N), 13434N (12382N), 13652N (12835N), and 13242N (12154N)*. *Kit Lot #13242N (Disc Lot #12154N) was shipped to Europe and not within the US.
- Product
- Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
- Recalling firm
- DiaSorin Molecular LLC
- Quantity
- 29495 kits
- Distribution
- US: AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV; and Worldwide: Kuwait, Australia, Israel, Italy, Canada, Chile, Puerto Rico, United Arab Emirates.
- Recall date
- January 12, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)