Cepheid Recall 94932
Description: Cepheid, Sample Collection Device, Part: 900-0370
Cepheid Recall 94932 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2584-2024 |
| Event ID | 94932 |
| Event Description | Cepheid, Sample Collection Device, Part: 900-0370 |
| Product Type | Devices |
| 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, Nicaragua, Germany, San Marino, Ecuador, New Caledonia, France, Austria, United Kingdom, Finland, Italy, Hong Kong, Kuwait, United Arab Emirates, Netherlands, Belgium, Monaco, Colombia, Spain, Portugal, Poland, Switzerland, Denmark, Jersey, Mexico |
| Quantity | 651,150 |
| Recall 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. |
| Device Classification | 20240821 |
| Device Code Info | UDI-DI: 28053326001523. Lot/Expiration: 230397900/ July 3, 2024; 230535300/ July 14, 2024; 230627500/ August 4, 2024; 231877400/ April 10, 2025 |
| Center Classification Date | 20240813 |
| Recall Initiation Date | 20240620 |
| Recalling Firm | Cepheid |
| Initial Notification | Letter |
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