Recall Z-0449-2021 ยท LIO Device, Specimen Collection
Thomas Scientific
Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
| Date | Jul 14, 2020 |
| Status | Open, Classified |
| Reason | The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval. |
| Root cause | No Marketing Application |
| Action | On 8/31/20, the firm provided FEMA with the recall letter, which was distributed to all affected users. Users were informed that product manufactured and distributed prior to Enforcement Discretion Approval was to be removed. The firm offered to replace any returned product. To report and receive replacement, customers should complete the included VTM Product Replacement Form and return it to QC@ThomasSci.com. Thomas Scientific will replace any product that has been returned. Please contact QC@ThomasSci.com for any requests for field support. |
| Quantity | 115,800 cs (100 vials/cs) |
| Distribution | US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KA, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.