Remel Inc Recall 87495
Description: 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.
Remel Inc Recall 87495 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1425-2021 |
| Event ID | 87495 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 19 units |
| Recall Reason | When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure. |
| Device Classification | 20210421 |
| Device Code Info | Lot Numbers: Lot 220711 Exp. 2021-2-17 |
| Center Classification Date | 20210413 |
| Recall Initiation Date | 20210310 |
| Recalling Firm | Remel Inc |
| Initial Notification | Letter |
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