Recall Z-1425-2021 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Remel Inc
Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.
| Date | Mar 10, 2021 |
| Status | Open, Classified |
| Reason | When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure. |
| Root cause | Under Investigation by firm |
| Action | The firm, ThermoFisher Scientific, sent an "Medical Device Field Action Recall" letter dated 3/10/2021 to its consignees on 03/10/2021. The letter described the product, problem and actions to be taken. The consignees were instructed to do the following: Review the reported test results should be determined by the appropriate technical expert. Please keep this notification on file. This notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. If you have any questions, please cont |
| Quantity | 19 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K892928 | HAEMOPHILUS TEST MEDIUM (AGAR) Remel Co., Jun 13, 1989 |