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Open, Classified

Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 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.

FDA Recall Z-1424-2021 · Posted None

Recalling FirmRemel Inc
Recall StatusOpen, Classified
Product CodeJSO
Date Initiated2021-03-10
Product Quantity408 units

Reason for Recall

When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.

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 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].

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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