Recall Z-0655-2021 ยท JSM Culture Media, Non-Propagating Transport
Hardy Diagnostics
Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents
| Date | Oct 23, 2020 |
| Status | Terminated |
| Reason | There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compromise the detection of COVID-19 by the final device used for testing. |
| Root cause | Material/Component Contamination |
| Action | On October 23, 2020, Hardy Diagnostics issued a "Urgent: Recall Notification" to affected consignees via US Mail, E-Mail, and/or Facsimile. In addition to informing consignees about the recalled device, the firm requested that consignees take the following actions: 1. Please retain this letter or post the letter where the product is stored to ensure the users are aware of this defect. 2. Notify any and all employees who may use the product. 3. If the product was further distributed, notify the consignees the product was distributed to. 4. Please complete the "Manufactured Item Product Rec |
| Quantity | 686,920 devices |
| Distribution | US Nationwide Distribution: CA, NC, AK, NY, OH, IL, NC, WI, SD, FL, DE, MI, MA, MD, GA, , TX, PA, IA, WV, ID, UT, KS, OR, CT, NY, WA, VA, TN, HI, AL, KY, MN, PR, MO, WI, AZ, SC, LA, AR, IN, NE, MS, NH, and OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.