Recall Z-2153-2023 ยท OOI Real Time Nucleic Acid Amplification System
DiaSorin Molecular LLC
Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452
| Date | Jul 18, 2023 (initiated Jun 14, 2023) |
| Status | Open, Classified |
| Reason | There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc. |
| Root cause | Under Investigation by firm |
| Action | On June 19, 2023 DiaSorin Molecular issued a "urgent: Medical Device Correction Notification to affected consignees via E-Mail. DiaSorin Molecular asked consignees to take the following actions: 1. Any remaining discs in inventory that are listed in the table below should be discarded. Replacement will be provided. 2. Any sample with an error code should be retested. 3. If leakage is suspected, the spillage should be removed, and the instrument surface should be decontaminated. Ensure the practice of Good Laboratory Procedures including regular cleaning. 4. Notify others within your net |
| Quantity | 4,7878 units |
| Distribution | Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV and the countries of Bangladesh, Canada, Israel, Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.