Recall Z-2531-2023 ยท JSD Culture Media, Selective Broth
Remel, Inc
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
| Date | Sep 8, 2023 (initiated Aug 14, 2023) |
| Status | Open, Classified |
| Reason | On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples |
| Root cause | Under Investigation by firm |
| Action | ThermoFisher SCIENTIFIC disseminated a "Medical Device Field Action Recall" to its consignees on 08/14/2023 by US mail. The notice explained the problem, the risk to health, and requested the following actions be taken: - Destroy any remaining affected product in inventory; - A review of reported test results should be evaluated by an appropriate technical expert; - Pass the notice to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred; - Keep the notice on file. The firm will replace the product. If yo |
| Quantity | 139 units (13,900 tests) |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K871447 | TODD HEWITT W/CNA (LIM BROTH) Remel Co., May 13, 1987 |