DiaSorin Molecular LLC Recall 89098
Description: Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
DiaSorin Molecular LLC Recall 89098 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0457-2022 |
| Event ID | 89098 |
| Event Description | Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455 |
| Product Type | Devices |
| 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. |
| Quantity | 29495 kits |
| Recall Reason | 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. |
| Device Classification | 20220112 |
| Device Code Info | 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. |
| Center Classification Date | 20220105 |
| Recall Initiation Date | 20211119 |
| Recalling Firm | DiaSorin Molecular LLC |
| Initial Notification | |
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