Recall Z-2584-2024 ยท JSM Culture Media, Non-Propagating Transport
Cepheid
Cepheid, Sample Collection Device, Part: 900-0370
| Date | Aug 14, 2024 (initiated Jun 20, 2024) |
| Status | Open, Classified |
| Reason | Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results. |
| Root cause | Under Investigation by firm |
| Action | On 6/20/24, "Urgent Medical Device Recall" notices dated 6/18/24 were sent to customers describing the product, problem and actions to taken. The notices informed them of the following: 1) Dispose of Collection/affected Devices from Copan lots you may currently have in use or in your inventory. 2) The quality issue with the Collection Device is intermittent, so the firm asks that if you receive a positive or negative test result, to please follow the Instructions for Use (IFU) for your specific assay, and your facility's protocol related to management of test results. 3) Share this informatio |
| Quantity | 651,150 |
| Distribution | Worldwide distribution: US (nationwide): IL, TX, OH, LA, NY, CA, MD, IA, MN, KY, NH, WI, MO, NC, UT, WA, FL, NJ, SC, CO, PA, SD, NE, MT, WV, GA, MA, RI, CT, DE, MS, OK, VA, ID, AZ, OR, MI, IN, TN, AL, KS, ME, AR, NV, HI, AK, NM, WY, VT, ND, DC OUS (foreign) to countries of: Chile, Ireland, Oman, Ni |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K946283 | COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM Copan Diagnostics, Inc., Mar 10, 1995 |