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.
Recall
- Recall Number
- Z-1425-2021
- Event Number
- 87495
- Firm
- Remel Inc
- FEI Number
- 1924669
- Product Code
- JSO
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- March 10, 2021
- Address
- 12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519
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.
When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
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 contact Technical Services Department at 800-255-6730 (US) or email [email protected]. You should complete the accompany Acknowledgment Form upon receipt and return to [email protected]. If you have any further questions, contact Director, Quality Assurance and Regulatory Affairs at 913-895-4077 or email: [email protected] Copy to: Beverly Marsh - [email protected].
US Nationwide distribution.
19 units